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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUPRAFLEX Cruz | Device | Percutaneous Coronary Intervention for multivessel disease |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NUIG | Galway | H91 TK33 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39825017 | Derived | 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. | |
| 39076220 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
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| SYNERGY |
| Device |
Percutaneous Coronary Intervention for multivessel disease |
|
| 24 months post-procedure |
| 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:
| 24 months post-procedure |
| Number of participants with all cause death | a comparison of numbers of participants with all cause death | 12 and 24 months post-procedure |
| Number of Participants with any stroke | a comparison of numbers of participants with any stroke | 12 and 24 months post-procedure |
| Number of Participants with any myocardial infarction | a comparison of numbers of participants with any myocardial infarction | 12 and 24 months post-procedure |
| Number of Participants with any (repeat) revascularisation | a comparison of number of participants with any (repeat) revascularisation | 12 and 24 months post-procedure |
| Number of vessels with vessel-related cardiovascular death | a comparison of numbers of vessels with vessel-related cardiovascular death | 12 and 24 months post-procedure |
| Number of vessels with vessel-related MI | a comparison of numbers of vessels with vessel-related MI | 12 and 24 months post-procedure |
| 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) | 12 and 24 months post-procedure |
| 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 | 12 and 24 months post-procedure |
| 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 | 12 and 24 months post-procedure |
| Number of participants with cardiovascular death | a comparison of numbers of participants with cardiovascular death | 12 and 24 months post-procedure |
| Number of participants with target vessel MI | a comparison of numbers of participants with target vessel MI | 12 and 24 months post-procedure |
| Number of participants with clinically-indicated target lesion revascularisation | a comparison of numbers of participants with clinically-indicated target lesion revascularisation | 12 and 24 months post-procedure |
| Number of participants with Definite/Probable Stent thrombosis | a comparison of numbers of participants with Definite/Probable Stent thrombosis | 12 and 24 months post-procedure |
| Number of participants with device success | a comparison of numbers of participants with device success | 7days post-procedure |
| Number of participants with procedure success | a comparison of numbers of participants with procedure success (Device success + free from POCE at discharge) | 7days post-procedure |
| 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. |
| 32928717 | 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. |