Non-inferiority of Angiography-derived Physiology Guidance Versus Usual Care in an All-comers PCI Population Treated With Unrestricted Use of the Healing-Targeted Supreme (HT Supreme) Drug-eluting Stent and P2Y12 Inhibitor Monotherapy After 1-month of Dual-antiplatelet Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,540
- 试验地点
- 19
- 主要终点
- Patient-oriented Composite Endpoint (PoCE)
研究概览
简要总结
PIONEER-IV is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance to LRDP and usual care in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent. Patients will be randomized to either angio-based physiology guidance angio-FFR (Quantitative Flow Ratio and coronary angiography-derived FFR, caFFR) or local routine diagnostic procedure (LRDP) and usual care. Patients will be treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2*1270) patients. All patients (both cohorts) must receive dual anti-platelet therapy, being aspirin (ASA) and ticagrelor for 1 month, followed by 11 months of ticagrelor only (i.e. monotherapy). At 1 year, ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator.
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
- Single (Participant)
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
- •Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
- •Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
- •The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
- •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 (follow-up) evaluations.
排除标准
- •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 intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
- •Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure;
- •Concurrent medical condition with a life expectancy of less than 3 years;
- •Currently participating in another trial and not yet at its primary endpoint;
- •Active pathological bleeding;
- •History of intracranial haemorrhage.
结局指标
主要结局
Patient-oriented Composite Endpoint (PoCE)
时间窗: 12 months
PoCE is a composite clinical endpoint of: * all-cause death; * any stroke, Modified Rankin scale, (MRS ≥1); * any myocardial infarction; * any clinically and physiologically driven revascularization.
次要结局
- Vessel-oriented composite endpoints (VoCE)(12, 24 and 36 months)
- Bleeding(12, 24 and 36 months follow-up)
- Device-oriented composite endpoint (DoCE)(12, 24 and 36 months)
- Myocardial Infarction (MI)(48 hours post-procedure)
- Device Success Rate(index procedure)
- Stent Thrombosis(Procedure, 12, 24 and 36 months)
- Target Vessel Failure (TVF)(12, 24 and 36 months)
研究者
Patrick Serruys
Professor of Interventional Cardiology & Innovation at the National University of Ireland, Galway, Ireland
National University of Ireland, Galway, Ireland