Multivessel TALENT

NCT04390672 | Active Not Recruiting DMC

• 1 other identifier: NUIG-2020-002
• Study Type: interventional
• Target: 1,550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

multi-vessel coronary artery disease; revascularization; quantitative flow ratio; fractional flow reserve; instant wave-free ratio; SYNTAX score; prasugrel monotherapy; ultra-thin strut sirolimus-eluting coronary stent

Outcome Measures

Primary Outcomes (1)

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

  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

  12 months post-procedure

Secondary Outcomes (17)

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

  24 months post-procedure

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

  24 months post-procedure

• Number of participants with all cause death

  12 and 24 months post-procedure

• Number of Participants with any stroke

  12 and 24 months post-procedure

• Number of Participants with any myocardial infarction

  12 and 24 months post-procedure

Study Arms (2)

SUPRAFLEX Cruz

EXPERIMENTAL

Percutaneous Coronary Intervention with the SUPRAFLEX Cruz Sirolimus Eluting Bioabsorbable Polymer Coronary Stent System. It is a balloon expandable sirolimus eluting stent with an bioabsorbable polymer coating.

Device: SUPRAFLEX Cruz

SYNERGY

ACTIVE COMPARATOR

Percutaneous Coronary Intervention with the SYNERGY EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with an bioabsorbable polymer coating.

Device: SYNERGY

Interventions

SUPRAFLEX Cruz DEVICE

Percutaneous Coronary Intervention for multivessel disease

SUPRAFLEX Cruz

SYNERGY DEVICE

Percutaneous Coronary Intervention for multivessel disease

SYNERGY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

NUIG

Galway, H91 TK33, Ireland

Location

Related Publications (3)

• Kageyama S, Revaiah PC, Tsung-Ying T, Miyashita K, Tobe A, O'Leary N, Reiber JHC, Tu S, Zaman A, Sabate M, Mollmann H, Sharif F, Lemoine J, Wlodarczak A, Garg S, Onuma Y, Serruys PW. Diffuseness of coronary artery disease impacts on immediate hemodynamic and predicted clinical outcomes. Sci Rep. 2025 Jan 17;15(1):2228. doi: 10.1038/s41598-025-85872-9.

  PMID: 39825017 DERIVED

• Ninomiya K, Serruys PW, Garg S, Hara H, Masuda S, Kageyama S, Kotoku N, Sevestre E, Kumar A, O'Kane P, Zaman A, Farah B, Magro M, Oemrawsingh RM, Mollmann H, Meneveau N, Achenbach S, Lemoine J, Allali A, Gallagher S, Wykrzykowska J, Lesiak M, Silvestri M, Wijns W, Sharif F, Onuma Y. The Utility of the SYNTAX Score II and SYNTAX Score 2020 for Identifying Patients with Three-Vessel Disease Eligible for Percutaneous Coronary Intervention in the Multivessel TALENT Trial: A Prospective Pilot Experience. Rev Cardiovasc Med. 2022 Apr 8;23(4):133. doi: 10.31083/j.rcm2304133. eCollection 2022 Apr.

  PMID: 39076220 DERIVED

• Hara H, Gao C, Kogame N, Ono M, Kawashima H, Wang R, Morel MA, O'Leary N, Sharif F, Mollmann H, Reiber JHC, Sabate M, Zaman A, Wijns W, Onuma Y, Serruys PW. A randomised controlled trial of the sirolimus-eluting biodegradable polymer ultra-thin Supraflex stent versus the everolimus-eluting biodegradable polymer SYNERGY stent for three-vessel coronary artery disease: rationale and design of the Multivessel TALENT trial. EuroIntervention. 2020 Dec 18;16(12):e997-e1004. doi: 10.4244/EIJ-D-20-00772.

  PMID: 32928717 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arteriosclerosis

Study Officials

• Patrick W. Serruys, MD, PhD

  National University of Ireland, Galway

  STUDY CHAIR

• William Wijns, MD, PhD

  National University of Ireland, Galway

  STUDY CHAIR

• Yoshinobu Onuma, MD, PhD

  National University of Ireland, Galway

  STUDY CHAIR

• Helge Moellmann, MD

  St. Johannes Hospital

  PRINCIPAL INVESTIGATOR

• Manel Sabate, MD, PhD

  Hospital Clínic of Barcelona

  PRINCIPAL INVESTIGATOR

• Azfar Zaman, MD

  Freeman Hospital and Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Established Professor of Interventional Medicine and Innovation, National University of Ireland, Galway (NUIG), Galway, Ireland

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 15, 2020
• Study Start: September 22, 2020
• Primary Completion: September 23, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IE (1)