Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT)
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|ClinicalTrials.gov Identifier: NCT02870140|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Stenosis||Device: SUPRAFLEX Device: XIENCE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1430 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Actual Study Start Date :||October 21, 2016|
|Actual Primary Completion Date :||September 20, 2018|
|Estimated Study Completion Date :||July 3, 2020|
Percutaneous Coronary Intervention with the SUPRAFLEX Sirolimus Eluting Bioabsorbable Polymer Coronary Stent System. It is a balloon expandable sirolimus eluting stent with an bioabsorbable polymer coating.
Percutaneous Coronary Intervention
Active Comparator: XIENCE
Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.
Percutaneous Coronary Intervention
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870140
|Study Chair:||P. W. Serruys, Prof. MD.||International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom|
|Study Chair:||U. Kaul, Prof. MD.||Fortis Escorts Heart Institute & Research Centre, New Delhi, India|
|Principal Investigator:||R. de Winter, Prof. MD.||Academisch Medisch Centrum, Amsterdam, The Netherlands|
|Principal Investigator:||A. Zaman, MD.||Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom|
|Study Director:||Gerrit-Anne van Es, PhD||ECRI-Trials B.V.|