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Coronary Artery DiseaseNCT04390672

Multivessel TALENT

A study testing SUPRAFLEX Cruz and SYNERGY in people with Coronary Artery Disease and Myocardial Ischemia, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SUPRAFLEX Cruz and SYNERGY
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,550 participants
Where
1 siteIreland
Study dates
22 Sep 2020to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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.

Who cannot join

  • 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).
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • NUIG

    Galway, H91 TK33

Other trials in Ireland

About this study

Official 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

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.

Being tested
SUPRAFLEX Cruz, SYNERGY
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
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arterial Occlusive Diseases, Vascular Diseases

What participants receive

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

  • SUPRAFLEX CruzDevice

    Percutaneous Coronary Intervention for multivessel disease

  • SYNERGYDevice

    Percutaneous Coronary Intervention for multivessel disease

Study groups in NCT04390672
Study groupRoleWhat they receive
SUPRAFLEX CruzExperimentalPercutaneous 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.
Receives: Device: SUPRAFLEX Cruz
SYNERGYActive comparatorPercutaneous 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.
Receives: Device: SYNERGY

What is being measured

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

  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

    Measured: 12 months post-procedure

Secondary outcomes (17)

  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)

    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).

    Measured: 24 months post-procedure

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

    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

    Measured: 24 months post-procedure

  3. Number of participants with all cause death

    a comparison of numbers of participants with all cause death

    Measured: 12 and 24 months post-procedure

  4. Number of Participants with any stroke

    a comparison of numbers of participants with any stroke

    Measured: 12 and 24 months post-procedure

  5. Number of Participants with any myocardial infarction

    a comparison of numbers of participants with any myocardial infarction

    Measured: 12 and 24 months post-procedure

  6. Number of Participants with any (repeat) revascularisation

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

    Measured: 12 and 24 months post-procedure

  7. Number of vessels with vessel-related cardiovascular death

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

    Measured: 12 and 24 months post-procedure

  8. Number of vessels with vessel-related MI

    a comparison of numbers of vessels with vessel-related MI

    Measured: 12 and 24 months post-procedure

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

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

    Measured: 12 and 24 months post-procedure

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

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

    Measured: 12 and 24 months post-procedure

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

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

    Measured: 12 and 24 months post-procedure

  12. Number of participants with cardiovascular death

    a comparison of numbers of participants with cardiovascular death

    Measured: 12 and 24 months post-procedure

  13. Number of participants with target vessel MI

    a comparison of numbers of participants with target vessel MI

    Measured: 12 and 24 months post-procedure

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

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

    Measured: 12 and 24 months post-procedure

  15. Number of participants with Definite/Probable Stent thrombosis

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

    Measured: 12 and 24 months post-procedure

  16. Number of participants with device success

    a comparison of numbers of participants with device success

    Measured: 7days post-procedure

  17. Number of participants with procedure success

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

    Measured: 7days post-procedure

Timeline

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

  1. First posted15 May 2020
  2. Study start22 Sep 2020
  3. Primary completion23 Sep 2025
  4. Study completionSep 2026 (estimated)

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
None (open label)
Enrolment
1,550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04390672
Sponsor's protocol ID
NUIG-2020-002
Status last verified
Feb 2026
First submitted
1 May 2020
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oshima A, Revaiah PC, Kanehama N, Wlodarczak A, Mollmann H, Moreno R, Dziarmaga M, Sabate M, Legutko J, Silvestri M, Lemoine J, Choudhury A, Ince H, Oner A, Sharif F, Biscaglia S, Kochman J, Wykrzykowska J, Lesiak M, Amat-Santos IJ, Kumar A, Meneveau N, Landt M, Magro M, Zaman A, Veerasamy M, Tarantini G, Farah B, O'kane P, Del Blanco BG, Gomez-Hospital JA, Jozwa R, Schmitz T, Anderson R, Achenbach S, Hoye A, McNeice A, Lauten A, Van Belle E, Bartus S, Wacinski P, Devadathan S, Bednarek A, Wlodarczak S, Gurav A, Farina J, Ferraz-Costa G, Paluszkiewicz J, Miyashita K, Tobe A, Chinhenzva A, Garg S, Sunny S, Ni Bheolain G, Harte E, Tsai TY, Onuma Y, Serruys PW. Standardised versus visual assessment of device success after percutaneous coronary intervention. EuroIntervention. 2026 Oct 5;22(19):e1048-e1063. doi: 10.4244/EIJ-D-26-00413.

    PubMed 42837202

  • 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.

    PubMed 39825017

  • 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.

    PubMed 39076220

  • 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.

    PubMed 32928717

Questions about this trial

What is this clinical trial studying?

A study testing SUPRAFLEX Cruz and SYNERGY in people with Coronary Artery Disease and Myocardial Ischemia, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.

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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. 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?

This study is still under way. Results are not available in the source record yet.

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?

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). 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 NCT04390672, which also lists 4 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 27 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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