Back to resultsThin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT)
Primary Purpose
Coronary Stenosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SUPRAFLEX
XIENCE
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Stenosis focused on measuring CAD, ACS, All comers, PCI
Eligibility Criteria
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.
Sites / Locations
- Research Centre BG-004
- Research Centre BG-001
- Research Centre HU-002
- Research Centre HU-001
- Research Centre IT-001
- Research Centre NL-007
- Research Centre NL-008
- Research Centre NL-009
- Research Centre NL-002
- Research Centre NL-003
- Research Centre PL-002
- Research Centre PL-005
- Research Centre NL-009
- Research Centre ES-003
- Research Centre ES-005
- Research Centre ES-012
- Research Centre ES-018
- Research Centre GB-021
- Research Centre GB-002
- Research Centre GB-010
- Research Centre GB-022
- Research Centre GB-013
- Research Centre GB-012
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SUPRAFLEX
XIENCE
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization
Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization
TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months)
Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)
Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)
Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR.
Stent thrombosis rates according to ARC classification
Full Information
NCT ID
NCT02870140
First Posted
August 12, 2016
Last Updated
December 16, 2020
Sponsor
ECRI bv
Collaborators
Sahajanand Medical Technologies Limited
1. Study Identification
Unique Protocol Identification Number
NCT02870140
Brief Title
Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
August 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECRI bv
Collaborators
Sahajanand Medical Technologies Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
Keywords
CAD, ACS, All comers, PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1435 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SUPRAFLEX
Arm Type
Experimental
Arm Description
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.
Arm Title
XIENCE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SUPRAFLEX
Intervention Description
Percutaneous Coronary Intervention
Intervention Type
Device
Intervention Name(s)
XIENCE
Intervention Description
Percutaneous Coronary Intervention
Primary Outcome Measure Information:
Title
Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group
Description
TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization.
Time Frame
12 months post-procedure
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)
Time Frame
30 days, 6 months, 1 year, 2 years and 3 years
Title
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
Title
Stent thrombosis rates according to ARC classification
Time Frame
30 days, 6 months, 1 year, 2 years and 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. W. Serruys, Prof. MD.
Organizational Affiliation
International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
U. Kaul, Prof. MD.
Organizational Affiliation
Fortis Escorts Heart Institute & Research Centre, New Delhi, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
R. de Winter, Prof. MD.
Organizational Affiliation
Academisch Medisch Centrum, Amsterdam, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A. Zaman, MD.
Organizational Affiliation
Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernest Spitzer, MD.
Organizational Affiliation
ECRI-Trials B.V. (E.Spitzer@ECRI-Trials.com)
Official's Role
Study Director
Facility Information:
Facility Name
Research Centre BG-004
City
Plovdiv
Country
Bulgaria
Facility Name
Research Centre BG-001
City
Sofia
Country
Bulgaria
Facility Name
Research Centre HU-002
City
Budapest
Country
Hungary
Facility Name
Research Centre HU-001
City
Szeged
Country
Hungary
Facility Name
Research Centre IT-001
City
Milan
Country
Italy
Facility Name
Research Centre NL-007
City
Amsterdam
Country
Netherlands
Facility Name
Research Centre NL-008
City
Breda
Country
Netherlands
Facility Name
Research Centre NL-009
City
Eindhoven
Country
Netherlands
Facility Name
Research Centre NL-002
City
Leeuwarden
Country
Netherlands
Facility Name
Research Centre NL-003
City
Rotterdam
Country
Netherlands
Facility Name
Research Centre PL-002
City
Chrzanow
Country
Poland
Facility Name
Research Centre PL-005
City
Kędzierzyn- Koźle
Country
Poland
Facility Name
Research Centre NL-009
City
Warsaw
Country
Poland
Facility Name
Research Centre ES-003
City
Barcelona
Country
Spain
Facility Name
Research Centre ES-005
City
Barcelona
Country
Spain
Facility Name
Research Centre ES-012
City
Madrid
Country
Spain
Facility Name
Research Centre ES-018
City
Vigo
Country
Spain
Facility Name
Research Centre GB-021
City
Belfast
Country
United Kingdom
Facility Name
Research Centre GB-002
City
Cardiff
Country
United Kingdom
Facility Name
Research Centre GB-010
City
Cottingham
Country
United Kingdom
Facility Name
Research Centre GB-022
City
London
Country
United Kingdom
Facility Name
Research Centre GB-013
City
Newcastle-Upon-Tyne
Country
United Kingdom
Facility Name
Research Centre GB-012
City
Stevenage
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy.
Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: Sahajanand Medical Technologies.It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.
Citations:
PubMed Identifier
35285804
Citation
de Winter RJ, Zaman A, Hara H, Gao C, Ono M, Garg S, Smits PC, Tonino PAL, Hofma SH, Moreno R, Choudhury A, Petrov I, Cequier A, Colombo A, Kaul U, Onuma Y, Serruys PW. Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial. EuroIntervention. 2022 Aug 19;18(6):492-502. doi: 10.4244/EIJ-D-21-00766.
Results Reference
derived
PubMed Identifier
34666500
Citation
Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.
Results Reference
derived
PubMed Identifier
30827782
Citation
Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28.
Results Reference
derived
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Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
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