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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,550
- 试验地点
- 2
- 主要终点
- Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Under the age of
- •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.
结局指标
主要结局
Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation
时间窗: 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
次要结局
- Number of Participants with any stroke(12 and 24 months post-procedure)
- Number of vessels with vessel-related cardiovascular death(12 and 24 months post-procedure)
- Number of participants with all cause death(12 and 24 months post-procedure)
- Number of Participants with any myocardial infarction(12 and 24 months post-procedure)
- Number of participants with device success(7days post-procedure)
- 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)
- Number of Participants with any (repeat) revascularisation(12 and 24 months post-procedure)
- Number 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)(12 and 24 months post-procedure)
- Number of participants with cardiovascular death(12 and 24 months post-procedure)
- Number of participants with target vessel MI(12 and 24 months post-procedure)
- Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation(24 months post-procedure)
- Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target lesion revascularization(12 and 24 months post-procedure)
- Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation(12 and 24 months post-procedure)
- Number of participants with Definite/Probable Stent thrombosis(12 and 24 months post-procedure)
- Number of participants with clinically-indicated target lesion revascularisation(12 and 24 months post-procedure)
- Number of participants with procedure success(7days post-procedure)
研究者
Patrick Serruys
Established Professor of Interventional Medicine and Innovation, National University of Ireland, Galway (NUIG), Galway, Ireland
National University of Ireland, Galway, Ireland