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Active, Not Recruiting

NCT Number: NCT04390672

Multivessel TALENT

Multivessel TALENT is a prospective, randomized, multi-center study comparing clinical outcomes between SUPRAFLEX Cruz and SYNERGY in approximately 1550 patients with de-novo three vessel disease undergoing percutaneous coronary intervention (PCI). Patients will be treated according to "state of art PCI"; not only treatment strategies based on the latest ESC guideline, such as SYNTAX Score II recommendation, Heart Team discussion, post-procedure intravascular imaging optimization, cholesterol reduction by statin or PCSK-9 inhibitor, but also exploratory treatment strategies based on the latest evidence, such as physiological assessment using quantitative flow ratio and prasugrel monotherapy following 1-month dual antiplatelet therapy after PCI.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NUIG

Galway, H91 TK33, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients' ≥18 years.
  • At least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, LCX and/or side branch, RCA and/or side branch) supplying viable myocardium without left main involvement.
  • The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.50 mm (no limitation on the number of treated lesions, vessels, or lesion length).
  • Patients with chronic coronary syndrome or stabilized acute coronary syndromes.
  • All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II, provided that the SYNTAX Score II recommends equipoise risk (PCI or CABG) or PCI only.
  • Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required evaluations.
  • Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly.

Exclusion criteria

  • Under the age of 18.
  • Unable to give informed consent.
  • Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice).
  • Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor.
  • Prior PCI or prior CABG.
  • Ongoing ST-elevation myocardial infarction (STEMI).
  • Cardiogenic shock is also an exclusion criteria.
  • Concurrent medical condition with a life expectancy of less than 2 years.
  • Currently participating in another trial and not yet at its primary endpoint.
  • Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis.
  • Previous intracranial haemorrhage.

Treatment and study plan

SUPRAFLEX CRUZ

Device

Percutaneous Coronary Intervention for multivessel disease

Synergy

Device

Percutaneous Coronary Intervention for multivessel disease

Primary outcomes

  1. Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation

    Time frame: 12 months post-procedure

    a non-inferiority comparison of Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEX Cruz cohort to the SYNERGY cohort at 12 months post-procedure. POCE is a composite clinical endpoint of:

    • All cause death;
    • Any stroke, Modified Rankin Scale (MRS ≥1);
    • Any myocardial infarction (MI);
    • Any (repeat) revascularisation

Secondary outcomes

  1. Number of vessels with a composite of vessel-related cardiovascular death, vessel-related MI, or CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)

    Time frame: 24 months post-procedure

    a superiority comparison in the as treated population (per vessel level) of the vessel-oriented composite endpoints (VOCE).

    VOCE is a composite clinical endpoint of:

    • Vessel-related cardiovascular death;
    • Vessel-related MI;
    • CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation).

  2. Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation

    Time frame: 24 months post-procedure

    a comparison of Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEX Cruz cohort to the SYNERGY cohort at 24 months post-procedure. POCE is a composite clinical endpoint of:

    • All cause death;
    • Any stroke, Modified Rankin Scale (MRS ≥1);
    • Any myocardial infarction (MI);
    • Any (repeat) revascularisation

  3. Number of participants with all cause death

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with all cause death

  4. Number of Participants with any stroke

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with any stroke

  5. Number of Participants with any myocardial infarction

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with any myocardial infarction

  6. Number of Participants with any (repeat) revascularisation

    Time frame: 12 and 24 months post-procedure

    a comparison of number of participants with any (repeat) revascularisation

  7. Number of vessels with vessel-related cardiovascular death

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of vessels with vessel-related cardiovascular death

  8. Number of vessels with vessel-related MI

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of vessels with vessel-related MI

  9. Number of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)

  10. Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target lesion revascularization

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with TLF / DOCE defined as cardiovascular death, target vessel MI and clinically-indicated target lesion revascularisation

  11. Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with TVF defined as cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation

  12. Number of participants with cardiovascular death

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with cardiovascular death

  13. Number of participants with target vessel MI

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with target vessel MI

  14. Number of participants with clinically-indicated target lesion revascularisation

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with clinically-indicated target lesion revascularisation

  15. Number of participants with Definite/Probable Stent thrombosis

    Time frame: 12 and 24 months post-procedure

    a comparison of numbers of participants with Definite/Probable Stent thrombosis

  16. Number of participants with device success

    Time frame: 7days post-procedure

    a comparison of numbers of participants with device success

  17. Number of participants with procedure success

    Time frame: 7days post-procedure

    a comparison of numbers of participants with procedure success (Device success + free from POCE at discharge)

Sponsors and collaborators

Lead sponsor

National University of Ireland, Galway, Ireland

Other

Registry information

Official study title

A Randomized Controlled Trial to Compare the Safety and Efficacy of siroliMUs-eLuTIng Biodegradable Polymer ulTrA-thin Stent (SUPRAFLEX Cruz) and Everolimus-eLuting Biodegradable Polymer Stent (SYNERGY) in treatmENT for Three-vessel Coronary Artery Disease: Multivessel TALENT

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
May 15, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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