The SYNTAX II trial started in August 2013, with first Ethics Approval achieved after two months at the Leeuwarden Medical Center in The Netherlands. All participating sites were active after 7 months from start of activities.
SYNTAX II included 22 sites in 4 countries, and were distributed as follows: The Netherlands (2 sites), UK (9 sites), Poland (4 sites), and Spain (7 sites).
The first patient was enrolled on 6 February 2014 at Hospital Clínico Universitario San Carlos, Madrid, Spain, with Dr. Escaned being the site Principal Investigator. Enrolment of all participants, amounting to 454 was achieved on 26 November 2015 at the Liverpool Heart and Chest Hospital, United Kingdom, with Dr. Appleby being the site Principal Investigator. The achieved rate of enrolment was 1 patient per site per month.
Enrolment per country was distributed as follows: United Kingdom: 230 patients, Spain: 150 patients, Poland: 38 patients, and The Netherlands: 36 patients. The top 3 enrolling sites in the SYNTAX II trial were:
The SYNTAX II trial achieved 1 year of follow-up on 12 January 2017, which was used for reporting the primary endpoint. 2-year follow-up was completed on 18 April 2018 and 3-year follow-up was completed on 15 April 2019. Final 5 years results are expected in 2021.