A prospective, Single-Centre study to investigate the plaque characteristics in the culprit vessels in young Indian patients (=18 - =40 yrs) with ACS undergoing PCI by Optical Coherence Tomography imaging. - YPS40

Dr Nityanand Tripathi0 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. Patient is = 18 and = 40 years of age and going for PCI of the culprit lesion (more than 90 % diameter stenosis)
•2. At least =1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between = 40 % and < 90%
•3. Patient has documented ACS (unstable angina, NSTEMI or STEMI within the previous 72 hours)
•4. Patient demonstrates a left ventricular ejection fraction (LVEF) of = 40% as measured prior to enrolment
•5. Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect

•1) Patients with a medical condition that limits the life expectancy to 1 years or less
•2) Patients scheduled to undergo surgery within 3 months that requires interruption of DAPT
•3) Women who are pregnant or planning to be pregnant
•4) Patients with allergy to contrast agents
•5) Patients with coronary artery occlusion occurring at a site where a stent has already been placed or in whom observation by OCT is considered difficult
•6) Patients in shock
•7) Patients with a history of adverse reactions to aspirin, clopidogrel, or prasugrel
•8) Patients who are ineligible for the study in the opinion of the investigator
•9) Patients in whom follow-up at 12 months after the index procedure is considered difficult
•10) Patients with renal failure with a serum creatinine level of 2.0 mg/dL or more at presentation (non-HD patients)
•11) Patients with active heart failure
•12) Patients with acute Mitral regurgitation.

发起方

Dr Nityanand Tripathi