ECRI News

 

ECRI Announces the Launch of the IVUS CHIP UPP Registry: Pioneering IVUS-Guided PCI for Complex Coronary Lesions in Underrepresented Demographic Groups

 

Rotterdam, July 29, 2025

 

The European Cardiovascular Research Institute (ECRI) is proud to announce the initiation of the IVUS CHIP UPP Registry, a ground-breaking prospective observational study designed to evaluate the safety and efficacy of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients with complex coronary lesions who belong to underrepresented demographic minorities in the United States. This registry addresses a critical gap in cardiovascular research by focusing on populations historically underrepresented in clinical trials, aiming to generate high-quality data that can inform guidelines and improve outcomes for diverse patient groups.

Complex coronary anatomy is prevalent in up to one-third of patients undergoing PCI and is associated with poorer clinical outcomes. International guidelines strongly recommend IVUS guidance for these procedures to optimize stent placement and reduce complications. However, data on lesion characteristics, procedural success, and long-term outcomes in census-defined minority groups remain scarce. The IVUS CHIP UPP Registry seeks to fill this void by enrolling approximately 1010 patients who self-identify within demographic minorities, as defined by the U.S. Census Bureau. By prioritizing these groups, the study not only enhances the inclusivity of cardiovascular research but also provides insights into how social determinants of health, access to care, and biological factors may influence treatment efficacy in diverse populations.

The registry's design is multicenter, single-arm, and observational, allowing for real-world data collection on procedural and clinical outcomes. Optimal stenting criteria include achieving a final minimal stent area greater than 5 mm² or more than 90% of the distal reference lumen, plaque burden less than 50% within 5 mm of stent edges, and no significant edge dissections. The primary endpoint is target-vessel failure at 1 year, a composite of cardiac death, target-vessel myocardial infarction, or clinically driven target-vessel revascularization. Secondary endpoints encompass individual components of the primary endpoint, along with procedural and imaging metrics. An additional prespecified analysis will merge registry data with 1-year results from the IVUS-CHIP randomized controlled trial using inverse probability of treatment weighting, enabling robust comparisons across broader patient cohorts.

This initiative underscores the importance of demographic representation in clinical research. As highlighted in the study's design paper, published in Cardiovascular Revascularization Medicine in June 2025, the geographical distribution of demographic groups across the United States—based on the 2020 U.S. Census—reveals significant concentrations of minorities in urban and rural areas with varying access to advanced cardiovascular care. Minorities, including Black, Hispanic, Asian, Native American, and Pacific Islander populations, often face higher burdens of coronary artery disease due to socioeconomic factors, comorbidities like diabetes and hypertension, and systemic barriers to healthcare. Yet, these groups are underrepresented in trials, leading to extrapolated treatments that may not fully account for unique physiological or cultural considerations. By targeting these populations, the IVUS CHIP UPP Registry aims to generate evidence that promotes equity in cardiovascular interventions, potentially reducing disparities in outcomes such as stent thrombosis or restenosis. This focus aligns with broader calls from health authorities to diversify trial enrollment, ensuring that innovations like IVUS-guided PCI benefit all segments of society.

Leading this effort is a distinguished team of investigators renowned for their contributions to interventional cardiology. Coordinating Principal Investigator Dr. David Kandzari, from the Piedmont Heart Institute in Atlanta, Georgia, is a globally recognized expert in complex PCI and device-based therapies. Co-Principal Investigator Dr. Dawn Abbott, from the Lifespan Cardiovascular Institute in Providence, Rhode Island, a pioneer in gender and demographic disparities research, has authored influential papers on IVUS utilization in high-risk PCI. Dr. Wayne Batchelor, President of the Inova Heart and Vascular Institute in Fairfax, Virginia, has made significant contributions to understanding racial disparities in PCI outcomes, leading the PLATINUM Diversity study, which highlighted differential stent performance across demographic groups. Together, these investigators bring decades of expertise, having collectively led trials that have shaped modern interventional practices.

ECRI, as the study's sponsor, continues its legacy of excellence in cardiovascular research. Founded as a non-profit institute, ECRI collaborates with academic leaders and industry to conduct high-impact trials adhering to ICH/GCP standards. The institute facilitates major studies like the FAST-III, OPTIMAL, and IVUS CHIP RCT. For the IVUS CHIP UPP Registry, ECRI continues its partnership with Cardialysis, a premier contract research organization (CRO) and Core Lab with 42+ years of expertise in full-service clinical trials in Europe. Cardialysis has supported landmark studies like the SYNTAX family trials, providing comprehensive imaging analysis and trial management. This registry marks Cardialysis’s first fully executed study in the United States, aligning with its strategic expansion into the U.S. market. ECRI’s Scientific Advisory Board, comprising world-class experts, drives innovations in trial design, resulting in publications that influence global guidelines and enhance patient care worldwide.

Funding for the IVUS CHIP UPP Registry is provided through a generous research grant from Boston Scientific Corporation, a leader in cardiovascular innovation based in Marlborough, Massachusetts. Boston Scientific has a storied history of advancing interventional cardiology, developing pioneering technologies like drug-eluting stents, IVUS systems, and structural heart devices. Their contributions include landmark trials demonstrating cost-effectiveness and clinical benefits in high-risk populations, as showcased at TCT conferences. With a broad portfolio of minimally invasive solutions, Boston Scientific has expanded cardiac care access through digital innovations, bridging gaps in underserved regions and earning numerous awards for meaningful advancements that enhance patient outcomes globally.

ECRI extends gratitude to the investigators, participating sites, and patients for their commitment to this vital research. The IVUS CHIP UPP Registry, registered at ClinicalTrials.gov under NCT06625801, represents a step forward in inclusive science, with enrollment ongoing and primary results anticipated in the coming years. For more information, visit www.ecri-trials.com or contact the ECRI team.

 

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ECRI announces enrollment completion of the FAST III randomized clinical trial in Europe

 

Rotterdam, May 31st, 2024. 

 

The European Cardiovascular Research Institute (ECRI) announces that enrollment is now completed for the FAST III trial, a multicenter European investigation on the use of angiography-based fractional flow reserve calculated by means of vessel-Fractional Flow Reserve software (CAAS vFFR, Pie Medical, The Netherlands) in patients undergoing coronary revascularization procedures. vFFR can assess whether a coronary artery narrowing is functionally severe and requires treatment, or not.

Assessment of coronary narrowing severity with physiology-based techniques is currently endorsed by European Guidelines on Myocardial Revascularization, and the use of invasive wires to measure pressure gradient (FFR catheters) is part of routine practice. More recently, methods based only on angiographic projections (without the need for introducing additional wires to the heart) have been developed and their accuracy validated against invasive wire-based FFR. FAST III will add to the evidence on the use of angio-based FFR in routine practice.

The study is overseen by an Executive Committee consisting of a panel of renowned experts in cardiovascular research, including Dr. Joost Daemen, Principal Investigator of the FAST III trial (Erasmus Medical Center, Rotterdam, the Netherlands), Prof. Robert Byrne (Mater Private Hospital, Dublin, Ireland), Prof. Adrian Banning (John Radcliffe Hospital, Oxford, United Kingdom), Prof. Ulf Landmesser (Charite Hospital, Berlin, Germany), Prof. Jan Tijssen (ECRI, Rotterdam, the Netherlands) and Dr. Ernest Spitzer (ECRI, Rotterdam, the Netherlands), as sponsor representative.

The sponsor acknowledges the tremendous partnership among the participating centers, the executive and steering committees, the trial committees including the CEC and DSMB, the coordinating cardiovascular research organization and coronary physiology core laboratories, and the grant-givers. Most importantly, the trust of patients that consent for trial participation allows the progress of medicine. The FAST III program deeply thanks the participation of each patient in the trial, aiming to improve clinical outcomes and healthcare overall.

An especial recognition to the research teams and interventionalists led by Dr. Joost Daemen (NL), Prof. Marco Barbierato (IT), Dr. Giovanni L. de Maria (UK), Prof. Eric van Belle (FR), Dr. Ignacio Amat-Santos (ES), Prof. Robert Byrne (IE), Prof. Ulf Landmesser (DE), who completed the study as largest national contributors. Every individual contribution has been significant and appreciation is shared with all participating centers. Similarly, ECRI wishes to acknowledge the passion and commitment of the Principal Investigator, Dr. Joost Daemen, whose leadership and passion on coronary physiology has maintained an incredible momentum for the trial.

Cardialysis, a scientifically-driven contract research organization with full European coverage, partners in the full-service execution of this trial. Congratulations for this milestone to Monique Schuijer (Enrollment Project Manager) and Nine Favie (Follow-up and Reporting Project Manager) as well as to Leonie van Meijl (Lead CRA) for the precise oversight and appreciated collaboration with the full study Team at Cardialysis and expert local monitors in the 7 countries. The follow-up of FAST III continues and the primary endpoint results are expected in 2025.

ECRI is a non-profit Institute that brings together a community of top clinical researchers, industry partners, and private/public funding partners in order to (1) perform clinical investigations that improve cardiovascular healthcare and, (2) perform these clinical investigations according to international regulations with strict monitoring of budgets and timelines. ECRI is the trial sponsor supported by research grants from Pie Medical Imaging (Maastricht, the Netherlands) and Siemens Healthineers AG (Erlangen, Germany). Without these generous research programs, the FAST III trial would not have been possible.

The design of the Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR guided revascularization (FAST III) trial has been reported previously in the American Heart Journal and it consists of a randomized controlled, open-label, international, non-inferiority, strategy trial (NCT04931771). A total of 2228 participants were randomized in a 1:1 fashion to either vFFR- or FFR-guided revascularization. This outcome trial enrolled participants in 37 sites and 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France), and will report its primary endpoint once all participants have completed 12 months of follow-up in 2025.

References:

• Scoccia A, Byrne RA, Banning AP, Landmesser U, Van Belle E, Amat-Santos IJ, Sabaté M, Tijssen JGP, Spitzer E, Daemen J. Fractional flow reserve or 3D-quantitative-coronary-angiography based vessel-FFR guided revascularization. Rationale and study design of the prospective randomized fast III trial. Am Heart J. 2023 Jun;260:1-8. doi: 10.1016/j.ahj.2023.02.003. Epub 2023 Feb 14. PMID: 36796573.
• www.academicresearchconsortium.org
• www.cardialysis.nl

  

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ECRI announces the appointment of Dr. Juan F. Iglesias as member of its Scientific Advisory Board.

 

Rotterdam, November 10th, 2023. 

 

The European Cardiovascular Research Institute (ECRI) is honored to welcome Dr. Juan Iglesias to its Scientific Advisory Board (SAB). ECRI is a non-profit foundation that brings together top clinical researchers and supporting grant-givers in order to perform clinical studies that improve cardiovascular health care and to perform these clinical studies according to international regulations and within pre-defined timelines.

Dr. Juan F. Iglesias is an interventional cardiologist at Geneva University Hospitals, and Privat Docent and Lecturer at the University of Geneva, Switzerland. He is board certified in general cardiology at Lausanne University Hospital and he specialized in interventional cardiology with a focus on complex and high-risk percutaneous coronary interventions including chronic total occlusions, intravascular imaging, and invasive coronary physiology.

Dr. Iglesias works as a consultant in interventional cardiology at Geneva University Hospitals. He is a fellow of the European Society of Cardiology (FESC) and the American College of Cardiology (FACC). He has authored and co-authored more than 150 articles, book chapters and scientific reviews. Dr Iglesias' areas of research are wide and include novel coronary stent technologies, invasive coronary physiology, acute coronary syndromes, transradial coronary interventions, antiplatelet therapy during and after PCI and renal denervation. 

With the addition of Dr. Iglesias to its SAB, ECRI aims to increase its efforts in designing and executing large and relevant randomized controlled trials in coronary revascularization strategies. With the advent of innovative technologies, both for treatment as well as for invasive assessment of coronary lesions, an accelerated global collaboration is warranted to expedite innovation and bring better therapies to patients. Switzerland is a strategic geography for ECRI as well, given the forward-looking implementation of regulations for medical devices, including established collaborations with the US Food and Drug Administration.

" Dr. Iglesias has a precise vision for the intricate management of coronary artery disease, derived from his daily practice as well as from conceptual frameworks, that once tested in clinical trials, may lead to groundbreaking strategies to treat this condition " - Ernest Spitzer, Chairman of the Board at ECRI Foundation.

  

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ECRI announces the appointment of Prof. Philippe Pibarot as member of its Scientific Advisory Board.

 

Rotterdam, October 5th, 2023. 

 

The European Cardiovascular Research Institute (ECRI) is honored to welcome Prof. Philippe Pibarot to its Scientific Advisory Board (SAB). ECRI is a non-profit foundation that brings together top clinical researchers and supporting grant-givers in order to perform clinical studies that improve cardiovascular health care and to perform these clinical studies according to international regulations and within pre-defined timelines.

Prof. Pibarot is full professor at the Department of Medicine of Laval University and he holds the Canada Research Chair (Level I) in Valvular Heart Disease (VHD) at the Québec Heart & Lung Institute. He is the head of Cardiology Research at Québec Heart & Lung Institute. He obtained a doctorate in veterinary medicine (DVM) in 1987 at the University Claude Bernard in Lyon, France and a PhD degree in biomedical sciences from the University of Montreal in April 1995. He has received the FACC, FAHA, FASE, FESC, FASE, FCCS credentials.

The objective of his research program is to develop and validate novel patient-oriented approaches to improve the diagnosis, prevention, and treatment of VHD. He is currently the principal investigator of several multicenter studies and trials funded by Canadian Institutes of Health Research through a 7-year Foundation grant. He is director of the Echocardiography Core Laboratory at the Québec Heart & Lung Institute. He has published more than 650 articles and presented >900 invited conferences in the course of his career. He is associate editor for Structural Heart and Eurointervention journals and Imaging section editor for the Journal of the American College of Cardiology. He received the Annual Achievement Award of the Canadian Society of Echocardiography (2010), the Research Achievement Award, Canadian Cardiovascular Society (2010), and the Feigenbaum Lecture Award, American Society of Echocardiography (2012), and a Doctorate Honoris Causa of University of Liège, Belgium (2017). He is an ex-officio member of the nucleus of the Council in Valvular heart Diseases of the European Society of Cardiology. He is a founding member of Heart Valve Voice Canada. He is among the most influential scientists in the field of Medicine according to the Clarivate Analytics Highly Cited Researchers 2018, 2019, 2020, and 2021.

With the addition of Prof. Pibarot to its SAB, ECRI aims to increase its efforst in designing and executing large and relevant structural heart disease trials in which imaging has a decisive role, with a European and Global reach, increasing collaboration with Canadian investigators.

" Prof. Pibarot is a star in his field, not only because of his vast expertise and track-record, but especially because of his unusual charisma, dedication, and passion for moving the field forward. We are honored to start this collaboration " - Ernest Spitzer, Chairman of the Board at ECRI Foundation.

 

 

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ECRI announces 2-year grant for Clinical Research Fellowship in Interventional Cardiology at Cardialysis at the #esccongress 

 

Amsterdam, August 26th, 2023. 

 

ECRI was founded in 2012 as a collaborative effort to perform investigator-initiated studies in the field of cardiology and became one of the leading Academic Research Organizations in the field of interventional cardiology in Europe. ECRI provides a structure facilitating the design and conduct of clinical trials according to ICH/GCP/ISO/MDR guidelines and standards. This unique initiative between thought leaders in the field of cardiology and Cardialysis, with its expertise in the field, creates an opportunity for multicenter, multinational investigator-initiated studies. Several multicenter randomized clinical trials sponsored by ECRI are currently being conducted by means of scientific grants from leading industries.

Cardialysis is a Dutch-based, quality-oriented, independent cardiac imaging Core Laboratory and a cardiology-focused Contract Research Organization (CRO) leveraging from 40 years in the field. It specializes in full-service, multi-national Device(+Pharma) Randomized Clinical Trials. Cardialysis facilitates coordination of expert committees, including Clinical Events Committees & Data and Safety Monitoring Boards in collaboration with Top European and Global experts. Cardialysis is a founding member of the Academic Research Consortium and EU-MDR Cardiovascular Research Collaboratory. It operates with global reach in compliance with European, US FDA, PMDA, and CFDA regulations.

Clinical Research Fellowship (CRF) Program in Interventional Cardiology

The CRF program is a clinical research fellowship in cardiology, which targets outstanding early- or mid-career physicians with research focus, who have the potential to excel in their field. The CRF program fosters diversity in clinical trials in line with ECRI's DIVERSIFY Program, which creates an inclusive academic environment where women and men from different ethnic backgrounds work together to address unmet medical needs in cardiology.

Two Core Themes:

Learning about designing, planning, executing, and reporting top quality clinical trials in cardiology, predominantly on coronary interventions, atherosclerosis, structural heart disease, heart failure, arrhythmias, and hypertension.

Learning about cardiac imaging quantitative analysis (invasive and non-invasive); independent committees (endpoint adjudication, data and safety monitoring boards; and safety oversight). 

Requirements to apply to the ECRI-Cardialysis CRF Program:

• Certified cardiologist plus a sub-specialty (>2 years) in interventional cardiology OR physician with a PhD in interventional cardiology.
• Minimum of 4 publications in peer-reviewed journals, including at least 2 as first author
• Familiar with basic statistics and able to perform routine statistical analyses
• English fluency
• Able and willing to move to The Netherlands for the duration of the program
• Do not hold, or have not previously held, an equivalent fellowship that provides an opportunity to establish an independent research group and therefore independent researcher status

Application Timelines

• Applications open at ESC 2023
• Deadline of applications: October 31, 2023
• Selection process and interviews: November 2023
• Announcement of results: End of December 2023
• Start of fellowship: As soon as possible in 2024

Application documents:

• Updated and signed Curriculum Vitae, detailing clinical and research experience
• 2 letters of recommendation from previous supervisors including contact details
• Motivational letter directed to the program director, including areas of expertise and areas of interest
• Submit all complete document to info@ecri-trias.com 

Selection process:

• Phase 1: Early screening based on information provided
• Phase 2: Introductory interviews with the program director
• Phase 3: Formal interview for selected candidates with the program director and 2 referees
• Phase 4: Final selection by the ECRI Foundation Board

Call for Action to Grant-Givers and Donors

The European Cardiovascular Research Institute accepts grants and donations for advance clinical research training of high-achieving academic physicians. For more information, please contact us at: info@ecri-trials.com

 

 

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ECRI announces enrollment completion of the OPTIMAL randomized clinical trial in Europe

 

Rotterdam, June 30 ^th , 2023. 

 

The European Cardiovascular Research Institute (ECRI) announces that enrollment is now completed for the OPTIMAL trial. OPTIMAL is a randomized controlled, multicenter, international, strategy trial. Its hypothesis is that an IVUS-guided approach is superior to an angio-guided approach when treating patients requiring percutaneous coronary intervention for left main coronary artery disease.

Observational studies and subgroup analyzes from clinical trials, have suggested a possible benefit from the use of intravascular ultrasound (IVUS) guidance when performing unprotected left main coronary artery percutaneous coronary intervention. However, the value of imaging with IVUS has never been proven in an appropriately powered randomized clinical trial. The OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound (OPTIMAL) trial is an ambitious program aiming to provide a definite answer, potentially impacting clinical guidelines as well as reimbursement in European countries. The primary endpoint of OPTIMAL is the Academic Research Consortium (ARC) patient-oriented composite endpoint (PoCE) which includes all-cause death, any stroke, any myocardial infarction and any repeat revascularization at 2 years follow-up.

The sponsor wishes to acknowledge the tremendous partnership among the participating centers, the steering committee, and the coordinating cardiovascular research organization. Enrollment started in July 2020, as the COVID-19 pandemic peaked in Europe and underwent significant challenges during the subsequent two years, for reasons known to the cardiovascular and clinical trial communities that can be summarized as follows: delays in regulatory reviews, staffing issues at the hospitals, hesitance of patients to attend hospitals, national restrictions including limited availability for monitoring visits, among other important factors. Despite these challenges, Investigators and Research Teams in the United Kingdom, Spain, and Italy, who are highly passionate about evidence-based medicine, continued efforts until achieving 100% enrollment today.

An especial recognition to the Research Teams and Interventionalists let by Dr. Daniel Jones (St Bartholomew's Hospital, Barts Health NHS Trust, London, England), Prof. Luca Testa (IRCCS Policlinico San Donato, Milan, Italy), and Dr. Pablo Piñón Esteban (Complexo Hospitalario Universitario A Coruña, A Coruña, Spain), who completed the study as largest contributors. Every individual contribution has been significant and appreciation is shared with all participating centers. Similarly, ECRI wishes to acknowledge the passion and commitment of the Steering Committee members, including Prof. Adrian Banning (Heart Centre, John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom), Prof. Luca Testa (IRCCS Policlinico San Donato, Milan, Italy), Dr. José M. de la Torre Hernández (Hospital Universitario Marqués de Valdecilla, Santander, Spain), and Giovanni Luigi De Maria (Heart Centre, John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom).

Cardialysis, a scientifically-driven cardiovascular research organization with full European coverage, partners in the full-service execution of the trial. Congratulations for this milestone to Anita van der Wal (OPTIMAL Project Manager) as well as to Céline Woltjes (Lead CRA) for the precise oversight and appreciated collaboration with the full study Team at Cardialysis and expert local monitors in the United Kingdom, Italy, and Spain. The follow-up of OPTIMAL continues and the primary endpoint results are expected in 2025.

ECRI is a non-profit Foundation that brings together a community of top clinical researchers, industry partners, and private/public funding partners in order to (1) perform clinical investigations that improve cardiovascular healthcare and, (2) perform these clinical investigations according to international regulations with strict monitoring of budgets and timelines. ECRI received research grants from Boston Scientific and Philips. Without these generous programs, regulated by the MedTech Europe Code of Ethical Business, the OPTIMAL trial would not have been possible.

The partnership among Investigators and Research Teams, Cardialysis, ECRI, and the Grant-Givers - Boston Scientific and Philips, represents the infrastructure to execute the investigation. The contribution of patients that consent trial participation is what makes it possible. The OPTIMAL program deeply thanks the participation of each patient in the trial, aiming to improve clinical outcomes and healthcare overall.

References:

• De Maria GL, Testa L, de la Torre Hernandez JM, Terentes-Printzios D, Emfietzoglou M, Scarsini R, Bedogni F, Spitzer E, Banning A. A multi-center, international, randomized, 2-year, parallel-group study to assess the superiority of IVUS-guided PCI versus qualitative angio-guided PCI in unprotected left main coronary artery (ULMCA) disease: Study protocol for OPTIMAL trial. PLoS One. 2022 Jan 7;17(1):e0260770. doi: 10.1371/journal.pone.0260770. PMID: 34995276; PMCID: PMC8740965.
• www.academicresearchconsortium.org
• www.cardialysis.nl

 

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ECRI announces the appointment of Dr. Victoria Delgado as member of its Scientific Advisory Board.

 

Rotterdam, October 26th, 2022. 

 

The European Cardiovascular Research Institute (ECRI) is thrilled to welcome Dr. Victoria Delgado to its Scientific Advisory Board (SAB). ECRI is a non-profit institute that brings together top clinical researchers and supporting grant-givers in order to perform clinical studies that improve cardiovascular health care and to perform these clinical studies according to international regulations and within pre-defined timelines.

Dr. Victoria Delgado is senior cardiologist, head of the cardiovascular imaging department at the University Hospital Germans Trias i Pujol, in Badalona (Barcelona, Spain) with specific focus on multimodality imaging. She has served as councilor of the ESC board from 2020-2022, twice as councilor of the European Association of Cardiovascular Imaging , one of the terms as chair of the Scientific documents, member of the EURObservational Research Program (EORP) and committee of the Clinical practice Guidelines.  She is Associate Editor of Circulation.

With over 750 publications in peer-reviewed journals, Dr. Delgado is one of the leading experts in the field of cardiovascular imaging worldwide, addressing advances and innovation in echocardiography, cardiac computed tomography, and cardiac magnetic resonance imaging, among other imaging techniques. Within investigations of the heart, Dr. Delgado has major contribution in both myocardial and valvular disease, with landmark publications.  List of publications available here .  Notably, Dr. Delago has participated in over 50 consensus and guideline documents within cardiology societies, including the European Society of Cardiology. 

With the addition of Dr. Delgado to its SAB, ECRI aims to increase its effectiveness in designing and executing large and relevant structural heart disease trials in which imaging has a decisive role. 

" It is a true privilege to work with Dr. Delgado and we look forward to learning from her and understanding research priorities in structural heart disease towards improving quality of life and patient care " - Ernest Spitzer, Managing Director of ECRI.

 

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ECRI announces the appointment of Prof. Luca Testa as member of its Scientific Advisory Board.

 

Rotterdam, August 8th, 2022. 

 

In line with its vision, the European Cardiovascular Research Institute (ECRI) welcomes Prof. Luca Testa to its Scientific Advisory Board (SAB). ECRI is a non-profit institute that brings together top clinical researchers and supporting grant-givers in order to perform clinical studies that improve cardiovascular health care and to perform these clinical studies according to international regulations and within pre-defined timelines.

Prof. Testa, MD, PhD, is an interventional cardiologist at the  Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Donato  in Milan, Italy, where he works as Head of the Coronary Revascularization Unit and Head of the Clinical Research Unit within the Department of Cardiology. Prof. Testa is also Contract Professor of Cardiology for the International MD program at the “Vita e Salute” University of San Raffaele Hospital in Milan, Italy. He has published more than 200 peer reviewed articles, covering several subjects especially in the field of transcatheter aortic valve replacement, with the manuscripts he authored/co-authored, he provided a significant contribution to the widespread diffusion of the TAVR technologies.  List of publications available here . 

Prof. Testa is academic editor, section editor and member of the board of several peer-reviewed journals. He is medical proctor for TAVR, CTOs, coronary imaging, and coronary physiology both in Europe and Middle East/Asia.

ECRI has a long-standing and outstanding partnership with Prof. Testa, who is Co-Principal Investigator of the OPTIMAL Trial ( NCT04111770 ), a landmark investigation in patients undergoing percutaneous coronary intervention for left main disease. Through his leadership, and in collaboration with his Co-Principal Investigator, Prof. Adrian Banning, the Steering Committee of the Trial, and the Team at Cardialysis, OPTIMAL went through the tremendous challenges of the COVID-19 pandemic but continued with passionate work with all participating centers. OPTIMAL is actively enrolling with consistent participation of up to 30 European interventional centers.

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ECRI announces the appointment of Dr. Alessandra Scoccia as Steering Committee Mentee in the FAST III Trial.

 

Rotterdam, February 22 ^nd , 2022. 

 

Following a recent announcement of the Steering Committee Mentee Program , ECRI is proud to introduce Dr. Alessandra Scoccia as the first Steering Committee Mentee at our Institute, working together with Dr. Joost Daemen as Mentor and Dr. Ernest Spitzer as Program Director. Her appointment is an important first step for ECRI's DIVERSIFY Program in promoting female leadership and multi-generational collaboration in CV research.

Dr. Scoccia is a cardiologist and researcher in Interventional Cardiology. She graduated with honors in Medicine and Surgery at Università degli Studi di Milano in 2016. Subsequently, in 2016 she was a resident at the department of Intensive Care at Western Health Hospital in Melbourne. Between 2017 and 2021 she completed her Cardiology residency at the University of Ferrara, progressively focusing her attention on Interventional Cardiology. During her cardiology training, Dr. Scoccia performed the initial steps of complex percutaneous coronary intervention, participating in a total of over 300 coronary and peripheral procedures. At present, she is active in cardiovascular research with a specific focus on innovations in the area of coronary physiology and its application on patients with coronary artery disease, with a particular interest in non-hyperemic pressure ratios and Angiography Based Vessel Fractional Flow Reserve. She has co-authored over 25 peer-reviewed publications. Currently, she is a PhD candidate at Erasmus Medical Center in Rotterdam.

“It is a great opportunity to be part of this project. I feel honored in being trusted by internationally-standing researchers, and I am eager to contribute to the FAST III Trial”

-Dr. Scoccia said when accepting the invitation.

The objective of FAST III (NCT04931771) is to determine the safety and effectiveness of an angiography-based vessel-Fractional Flow Reserve guided strategy versus an invasive FFR guided strategy to guide coronary revascularization in patients with intermediate coronary artery stenosis. This randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial aims to enroll a total of 2228 patients, in 7 European countries and approximately 35 hospitals. The Principal Investigator is Dr. Joost Daemen (Erasmus Medical Center, Rotterdam, The Netherlands).

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ECRI launches its Steering Committee Mentee Program, becoming the first cardiovascular research institute in Europe fostering training of early or mid-career physicians on cardiovascular clinical trials oversight. The Steering Committee Mentee Program is a first step in ECRI's DIVERSIFY Initiative.  

 

Rotterdam, February 28 ^th , 2022. 

 

Overseeing the execution of clinical trials requires clinical, academic, methodological, and operational expertise. ECRI has defined as a priority consequently the need for supplementing clinical and academic profiles with exposure to ongoing clinical trials within a Steering Committee in order to accelerate the expertise required for designing, planning, and overseeing large scale clinical investigations.

In compliance with GCP and formal requirements, a Steering Committee Mentee at ECRI formally joins the committee with a Mentor within the Committee. While ideally the Mentee would join the committee until the completion of the study and participate in its reporting, the duration of this experience is planned for a minimum of 12 months.

ECRI works together with the Mentor and Mentee in reviewing critical trial execution literature and regulations, as well as fostering methodological and operational dialogue. Importantly, best practices on confidentiality, firewalls among clinical trial processes, considerations on endpoint adjudication, data safety monitoring boards, and safety reporting procedures are studied.

The program is designed for early or mid-career physicians who have experience in the relevant trial field and have a genuine interest in clinical trials. Mentees are selected based on an academic profile supported with at least 4 articles published in peer-reviewed journals.

The ECRI's Steering Committee Mentee Program fosters diversity in clinical trials in line with ECRI's DIVERSIFY Initiative. The ECRI's DIVERSIFY Initiative  creates an academic environment where women and men from different ethnic backgrounds work together to address unmet medical needs in cardiology.