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

Coronary Stenosis Clinical Trial

— TALENT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870140
• Other study ID #: ECRI-007
• Status: Completed
• Phase: N/A
• Start date: October 21, 2016
• Est. completion date: August 26, 2020

Study information

• Verified date: December 2020
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1435
• Est. completion date: August 26, 2020
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All comers" patients:

• Male or female patients 18 years or older;
• Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
• The vessel should have a reference vessel diameter ranging from =2.25 mm to =4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
• The patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Patient is willing to comply with all protocol-required evaluations.

Exclusion Criteria:

• Known pregnancy or breastfeeding at time of randomization;
• Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
• Any PCI treatment within 6 months (<6 months) prior to the index procedure.
• Concurrent medical condition with a life expectancy of less than 12 months.
• The patient is unwilling/ not able to return for outpatient clinic at 12 months follow-up.
• Currently participating in another trial and not yet at its primary endpoint.

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• SUPRAFLEX
Percutaneous Coronary Intervention
• XIENCE
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Bulgaria	Research Centre BG-004	Plovdiv
Bulgaria	Research Centre BG-001	Sofia
Hungary	Research Centre HU-002	Budapest
Hungary	Research Centre HU-001	Szeged
Italy	Research Centre IT-001	Milan
Netherlands	Research Centre NL-007	Amsterdam
Netherlands	Research Centre NL-008	Breda
Netherlands	Research Centre NL-009	Eindhoven
Netherlands	Research Centre NL-002	Leeuwarden
Netherlands	Research Centre NL-003	Rotterdam
Poland	Research Centre PL-002	Chrzanow
Poland	Research Centre PL-005	Kedzierzyn- Kozle
Poland	Research Centre NL-009	Warsaw
Spain	Research Centre ES-003	Barcelona
Spain	Research Centre ES-005	Barcelona
Spain	Research Centre ES-012	Madrid
Spain	Research Centre ES-018	Vigo
United Kingdom	Research Centre GB-021	Belfast
United Kingdom	Research Centre GB-002	Cardiff
United Kingdom	Research Centre GB-010	Cottingham
United Kingdom	Research Centre GB-022	London
United Kingdom	Research Centre GB-013	Newcastle-Upon-Tyne
United Kingdom	Research Centre GB-012	Stevenage

Sponsors (2)

Lead Sponsor	Collaborator
ECRI bv	Sahajanand Medical Technologies Pvt. Ltd.

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group	TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization.	12 months post-procedure
Secondary	Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization		30 days, 6 months, 1 year, 2 years and 3 years
Secondary	Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization		30 days, 6 months, 1 year, 2 years and 3 years
Secondary	TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months)		30 days, 6 months, 1 year, 2 years and 3 years
Secondary	Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)		30 days, 6 months, 1 year, 2 years and 3 years
Secondary	Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)		30 days, 6 months, 1 year, 2 years and 3 years
Secondary	Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR.		30 days, 6 months, 1 year, 2 years and 3 years
Secondary	Stent thrombosis rates according to ARC classification		30 days, 6 months, 1 year, 2 years and 3 years