Coronary Stenosis Clinical Trial
— TALENTOfficial 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)
Verified date | December 2020 |
Source | ECRI bv |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
ECRI bv | Sahajanand Medical Technologies Pvt. Ltd. |
Bulgaria, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom,
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 |
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