Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent — TALENT  

Coronary Stenosis Clinical Trial

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 Lesion(s)

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Coronary Stenosis

• NCT number: NCT02870140
• Study type: Interventional
• Source: ECRI bv
• Status: Completed
• Phase: N/A
• Start date: October 21, 2016
• Completion date: August 26, 2020