Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02870140
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2016-08-12
Brief Title:
Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
Sponsor:
ECRI bv
Organization:
ECRI bv
Study Overview
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 Lesions
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TALENT
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 Description:
This is a prospective randomized 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None