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Coronary StenosisTALENTNCT02870140

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

A study testing SUPRAFLEX and XIENCE in people with Coronary Stenosis, run by ECRI bv at 23 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Stenosis
What is being tested?
SUPRAFLEX and XIENCE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,435 participants
Where
23 sitesin 7 countries
Study dates
21 Oct 2016to 26 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

23 sites in 7 countries.

23 sites in 7 countries

United Kingdom6 sites

  • Research Centre GB-021

    Belfast

  • Research Centre GB-002

    Cardiff

  • Research Centre GB-010

    Cottingham

  • Research Centre GB-022

    London

  • Research Centre GB-013

    Newcastle upon Tyne

  • Research Centre GB-012

    Stevenage

Other trials in United Kingdom

Netherlands5 sites

  • Research Centre NL-007

    Amsterdam

  • Research Centre NL-008

    Breda

  • Research Centre NL-009

    Eindhoven

  • Research Centre NL-002

    Leeuwarden

  • Research Centre NL-003

    Rotterdam

Other trials in Netherlands

Spain4 sites

  • Research Centre ES-003

    Barcelona

  • Research Centre ES-005

    Barcelona

  • Research Centre ES-012

    Madrid

  • Research Centre ES-018

    Vigo

Other trials in Spain

Poland3 sites

  • Research Centre PL-002

    Chrzanów

  • Research Centre PL-005

    Kędzierzyn-Koźle

  • Research Centre NL-009

    Warsaw

Other trials in Poland

Bulgaria2 sites

  • Research Centre BG-004

    Plovdiv

  • Research Centre BG-001

    Sofia

Other trials in Bulgaria

Hungary2 sites

  • Research Centre HU-002

    Budapest

  • Research Centre HU-001

    Szeged

Other trials in Hungary

Italy1 site

  • Research Centre IT-001

    Milan

Other trials in Italy

About this study

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)

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.

Read the 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.

Being tested
SUPRAFLEX, XIENCE
Keywords
CAD, ACS, All comers, PCI
Medical subject headings
Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUPRAFLEXDevice

    Percutaneous Coronary Intervention

  • XIENCEDevice

    Percutaneous Coronary Intervention

Study groups in NCT02870140
Study groupRoleWhat they receive
SUPRAFLEXExperimentalPercutaneous 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.
Receives: Device: SUPRAFLEX
XIENCEActive comparatorPercutaneous 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.
Receives: Device: XIENCE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post-procedure

Secondary outcomes (7)

  1. Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization

    Measured: 30 days, 6 months, 1 year, 2 years and 3 years

  2. Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization

    Measured: 30 days, 6 months, 1 year, 2 years and 3 years

  3. TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months)

    Measured: 30 days, 6 months, 1 year, 2 years and 3 years

  4. Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)

    Measured: 30 days, 6 months, 1 year, 2 years and 3 years

  5. Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)

    Measured: 30 days, 6 months, 1 year, 2 years and 3 years

  6. Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR.

    Measured: 30 days, 6 months, 1 year, 2 years and 3 years

  7. Stent thrombosis rates according to ARC classification

    Measured: 30 days, 6 months, 1 year, 2 years and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study start21 Oct 2016
  3. Primary completion20 Sep 2018
  4. Study completion26 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870140
Sponsor's protocol ID
ECRI-007
Acronym
TALENT
Status last verified
Dec 2020
First submitted
12 Aug 2016
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: 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.

Publications

  • 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.

    PubMed 35285804

  • 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.

    PubMed 34666500

  • 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.

    PubMed 30827782

Questions about this trial

What is this clinical trial studying?

A study testing SUPRAFLEX and XIENCE in people with Coronary Stenosis, run by ECRI bv at 23 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United Kingdom, Netherlands, Spain, Poland, Bulgaria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870140, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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