A randomized controlled trial to compare the safety and efficacy of siroliMUs-eLuTIng biodegradable polymer ulTrA-thin stent (SUPRAFLEXTM Cruz) and everolimus-eLuting biodegradable polymer stent (SYNERGYTM) in treatmENT for three-vessel coronary artery disease - Multivessel TALENT

Clinical Science Institute, National University of Ireland, Galway,0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年7月8日

研究概览

暂无简介。

•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*;
•*patients with ostial LAD or ostial LCX - Medina 0,0,1 or Medina 0,1,0 - may be
•enrolled; Patients with hypoplastic RCA (or LCX) with absence of descending
•posterior and presence of a lesion in the LAD and LCX (or RCA) territories may
•be included in the trial as a 3VD equivalent.
•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
•4. Patients with chronic coronary syndrome1 or stabilized acute coronary
•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.

•1. Under the age of 18.
•2. Unable to give informed consent.
•3. Patient is a woman who is pregnant or nursing;
•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
•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

发起方

Clinical Science Institute, National University of Ireland, Galway,