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

December 16, 2020 updated by: ECRI bv

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1435

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SUPRAFLEX
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.
Device: SUPRAFLEX
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.
Device: XIENCE
Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis rates according to ARC classification
Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years
30 days, 6 months, 1 year, 2 years and 3 years
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
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
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
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
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
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
30 days, 6 months, 1 year, 2 years and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECRI bv

Collaborators

Sahajanand Medical Technologies Pvt. Ltd.

Investigators

  • Principal Investigator: R. de Winter, Prof. MD., Academisch Medisch Centrum, Amsterdam, the Netherlands
  • 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: A. Zaman, MD., Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom
  • Study Director: Ernest Spitzer, MD., ECRI-Trials B.V. (E.Spitzer@ECRI-Trials.com)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2016

Primary Completion (Actual)

September 20, 2018

Study Completion (Actual)

August 26, 2020

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECRI-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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