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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02870140 |
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Date of registration:
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12/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
TALENT |
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Scientific title:
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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) |
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Date of first enrolment:
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October 21, 2016 |
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Target sample size:
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1430 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02870140 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Bulgaria
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Hungary
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Italy
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Netherlands
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Poland
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Spain
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United Kingdom
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Contacts
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Name:
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Gerrit-Anne van Es, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ECRI-Trials B.V. |
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Name:
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A. Zaman, MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom |
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Name:
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U. Kaul, Prof. MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fortis Escorts Heart Institute & Research Centre, New Delhi, India |
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Name:
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P. W. Serruys, Prof. MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom |
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Name:
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R. de Winter, Prof. MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academisch Medisch Centrum, Amsterdam, The Netherlands |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Stenosis
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Intervention(s)
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Device: SUPRAFLEX
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Device: XIENCE
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Stent thrombosis rates according to ARC classification
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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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]
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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]
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Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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