Multivessel TALENT

National University of Ireland, Galway, Ireland

Status: Active, not recruiting

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

Treatments: Device: SYNERGY; Device: SUPRAFLEX Cruz

Study type: Interventional

Funder types: Other

Identifiers

NCT04390672

NUIG-2020-002

Details and patient eligibility

About

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.

Enrollment: 1,550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,550 participants in 2 patient groups

SUPRAFLEX Cruz

Experimental group

Description:

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.

Treatment:

Device: SUPRAFLEX Cruz

SYNERGY

Active Comparator group

Description:

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.

Treatment:

Device: SYNERGY