Multivessel TALENT

Not Applicable

Active, not recruiting

• Conditions: Myocardial Ischemia; Vascular Diseases; Coronary Disease; Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases
• Interventions: Device: SUPRAFLEX Cruz; Device: SYNERGY

• Registration Number: NCT04390672
• Lead Sponsor: National University of Ireland, Galway, Ireland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-15
• Study Start: 2020-09-22
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1550

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SUPRAFLEX Cruz	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.
SYNERGY	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation	12 months post-procedure	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with any stroke	12 and 24 months post-procedure	a comparison of numbers of participants with any stroke
Number of vessels with vessel-related cardiovascular death	12 and 24 months post-procedure	a comparison of numbers of vessels with vessel-related cardiovascular death
Number of participants with all cause death	12 and 24 months post-procedure	a comparison of numbers of participants with all cause death
Number of Participants with any myocardial infarction	12 and 24 months post-procedure	a comparison of numbers of participants with any myocardial infarction
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	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).
Number of Participants with any (repeat) revascularisation	12 and 24 months post-procedure	a comparison of number of participants with any (repeat) revascularisation
Number of vessels with vessel-related MI	12 and 24 months post-procedure	a comparison of numbers of vessels with vessel-related MI
Number of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)	12 and 24 months post-procedure	a comparison of numbers of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)
Number of participants with cardiovascular death	12 and 24 months post-procedure	a comparison of numbers of participants with cardiovascular death
Number of participants with target vessel MI	12 and 24 months post-procedure	a comparison of numbers of participants with target vessel MI
Number of participants with device success	7days post-procedure	a comparison of numbers of participants with device success
Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation	24 months post-procedure	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
Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target lesion revascularization	12 and 24 months post-procedure	a comparison of numbers of participants with TLF / DOCE defined as cardiovascular death, target vessel MI and clinically-indicated target lesion revascularisation
Number of participants with clinically-indicated target lesion revascularisation	12 and 24 months post-procedure	a comparison of numbers of participants with clinically-indicated target lesion revascularisation
Number of participants with procedure success	7days post-procedure	a comparison of numbers of participants with procedure success (Device success + free from POCE at discharge)
Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation	12 and 24 months post-procedure	a comparison of numbers of participants with TVF defined as cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation
Number of participants with Definite/Probable Stent thrombosis	12 and 24 months post-procedure	a comparison of numbers of participants with Definite/Probable Stent thrombosis

Trial Locations

Locations (1)

NUIG; 🇮🇪 Galway, Ireland