Clinical Trial: Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Multicenter Randomized Post Market All-comer Trial to Assess the Safety and Effectiveness of the SUPRAFLEX Sirolimus-eluting Coronary Stent System for the Treatment of Atherosclerotic Le

Brief Summary: The primary objective of this study is to compare the performance of SUPRAFLEX to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

Detailed Summary:

This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE 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). The objective is to compare the SUPRAFLEX SES with the XIENCE EES with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population.

All patients will be (at minimum) contacted at 30 days, 6 months, and 12 months post procedure to assess clinical status and adverse events. The 30 day and 12 month will be a clinic visit. All patients will have annual contact through 3 years follow-up to assess clinical status and adverse events.


Sponsor: ECRI bv

Current Primary Outcome: Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group [ Time Frame: 12 months post-procedure ]

TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  • Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  • TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months) [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  • Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular) [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  • Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI) [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  • Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR. [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  • Stent thrombosis rates according to ARC classification [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]


Original Secondary Outcome: Same as current

Information By: ECRI bv

Dates:
Date Received: August 12, 2016
Date Started: October 2016
Date Completion: October 2020
Last Updated: May 1, 2017
Last Verified: May 2017