ltra-Thin strUt versus XiencE in a Diabetic pOpulation withMulti-Vessel Disease– 2– India Study ((TUXEDO-2-India))

Academics and Research Department Batra Hospital Medical Research Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Age greater or equal to 18 years
•2.Patient with diabetes mellitus (Type 1 or Type 2)
•3.Angiographically confirmed multivessel CAD [critical (greater or equal to 70 percent) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA]. The population will consist of approximately 85percent patients with triple vessel disease
•4.Angiographic characteristics amenable to PCI as decided by the heart team
•5.Indication for revascularization based upon symptoms of angina or angina equivalents andor objective evidence of myocardial ischemia
•6.Willing to comply with all follow-up required study visits
•7.Signed informed consent

•1.Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
•2.Prior CABG surgery.
•3.Prior PCI with stent implantation within 6 months.
•4.Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score greater 1.
•5.Prior history of significant bleeding (within the previous 6 months) that might preclude use of dual antiplatelet therapy.
•6.In-stent restenosis of a target vessel.
•7.Two or more chronic total occlusions in major coronary territories that are targeted for revascularization.
•8.Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization.
•9.Contraindication to PCI because of a coexisting clinical condition
•10.Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor or prasugrel.
•11.Extra-cardiac illness that is expected to limit survival to less than 5 years.
•12.Women who are pregnant, nursing, or who plans to become pregnant while the study.
•13.Concurrent enrollment in another clinical trial

发起方

Academics and Research Department Batra Hospital Medical Research Centre