Multivessel TALENT

  • STATUS
    Recruiting
  • End date
    Jun 9, 2025
  • participants needed
    1550
  • sponsor
    National University of Ireland, Galway, Ireland
Updated on 9 May 2022
stenosis
percutaneous coronary intervention
prasugrel
antiplatelet therapy
hmg-coa reductase inhibitor
coronary bypass
cholesterol measurement
hmg-coa reductase inhibitors

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.

Details
Condition Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arterial Occlusive Diseases, Vascular Diseases
Treatment Synergy, SUPRAFLEX Cruz
Clinical Study IdentifierNCT04390672
SponsorNational University of Ireland, Galway, Ireland
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

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
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