Multivessel TALENT

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arterial Occlusive Diseases, Vascular Diseases

Intervention / Treatment
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* Device: SUPRAFLEX Cruz
* Device: SYNERGY


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUPRAFLEX Cruz<br>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<br>* Percutaneous Coronary Intervention for multivessel disease<br>|
| Active Comparator: SYNERGY<br>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<br>* Percutaneous Coronary Intervention for multivessel disease<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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