Talent

 

This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX SES and XIENCE EES in a “Real world, all comers” patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions).

1,430 patients will be enrolled to receive treatment with either the study device (SUPRAFLEX) or the control device (XIENCE).

All patients will be contacted at 30 days, 6 months, and 12 months and annually through 3 years follow-up to assess clinical status and adverse events.

The primary endpoint for this trial is a non-inferiority comparison of the device-oriented composite endpoint Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group at 12 months post-procedure. TLF is a composite of clinical endpoint of

  • cardiac death,
  • target vessel myocardial infarction* and
  • clinically-indicated target lesion revascularization.

*SCAI consensus for peri-procedure MI ≤48 hours, and 3rd universal definition for MI >48 hours after index procedure.

The TALENT trial is registered at clinicaltrials.gov:

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