Multivessel TALENT

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Coronary Disease; Arterial Occlusive Diseases
• Intervention / Treatment: Device: SUPRAFLEX Cruz; Device: SYNERGY

• Study Type: Interventional
• Enrollment (Estimated): 1550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick W. Serruys, MD, PhD; Phone Number: +353 91459047; Email: multivtcoord@nuigalway.ie

Study Locations

• Ireland
  • Galway, Ireland, H91 TK33
    • Recruiting
    • NUIG
    • Contact: Faisal Sharif

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients' ≥18 years.
2. 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.
3. 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).
4. Patients with chronic coronary syndrome or stabilized acute coronary syndromes.
5. 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.
6. 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.
7. Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly.

Exclusion Criteria:

1. Under the age of 18.
2. Unable to give informed consent.
3. 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).
4. Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor.
5. Prior PCI or prior CABG.
6. Ongoing ST-elevation myocardial infarction (STEMI).
7. Cardiogenic shock is also an exclusion criteria.
8. Concurrent medical condition with a life expectancy of less than 2 years.
9. Currently participating in another trial and not yet at its primary endpoint.
10. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis.
11. Previous intracranial haemorrhage.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUPRAFLEX Cruz; 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; Percutaneous Coronary Intervention for multivessel disease
Active Comparator: SYNERGY; 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; Percutaneous Coronary Intervention for multivessel disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: All cause death;; Any stroke, Modified Rankin Scale (MRS ≥1);; Any myocardial infarction (MI);; Any (repeat) revascularisation	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	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: Vessel-related cardiovascular death;; Vessel-related MI;; 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	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	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

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Investigators: Study Chair: Patrick W. Serruys, MD, PhD, National University of Ireland, Galway; Study Chair: William Wijns, MD, PhD, National University of Ireland, Galway; Principal Investigator: Helge Moellmann, MD, St. Johannes Hospital; Principal Investigator: Manel Sabate, MD, PhD, Hospital Clinic of Barcelona; Principal Investigator: Azfar Zaman, MD, Freeman Hospital and Newcastle University; Study Chair: Yoshinobu Onuma, MD, PhD, National University of Ireland, Galway

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: revascularization; quantitative flow ratio; fractional flow reserve; multi-vessel coronary artery disease; instant wave-free ratio; SYNTAX score; prasugrel monotherapy; ultra-thin strut sirolimus-eluting coronary stent
• Additional Relevant MeSH Terms: Arteriosclerosis; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: NUIG-2020-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No