on-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: the PIONEER IV trial - PIONEER-IV Study

niversity of Galway-Prof.James Livesey (Vice President of Research)0 个研究点目标入组 595 人开始时间: 待定最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•1. Male or female patient >=18 years of age;
•2. Patient has chronic stable angina, acute coronary syndromes or silent
•3. 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;
•4. 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);
•5. 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.

•1. 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);
•2. Known intolerance to cobalt chromium, and medications such as sirolimus,
•aspirin, heparin, bivalirudin or P2Y12 inhibitors;
•3. Planned major elective surgery requiring discontinuation of (D)APT within 12
•months of procedure;
•4. Concurrent medical condition with a life expectancy of less than 3 years;
•5. Currently participating in another trial and not yet at its primary
•6. Active pathological bleeding;
•7. History of intracranial haemorrhage.

发起方

niversity of Galway-Prof.James Livesey (Vice President of Research)