A prospective, post marketing clinical follow up study to evaluate the safety and performance of Polymer Free Sirolimus Eluting Coronary Stent System in real world Indian population.

Translumina Therapeutics LLP0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•1.Age > 18 years.
•2.Patients who can provide informed consent form in writing to provide data for the study.
•3.Patients who allow their data to be collected for the study at predefined follow-up periods.
•4.Patients that need a treatment with drug eluting stent.
•5.Presence of one or more coronary artery stenosis in a native coronary artery or a saphenous vein graft from 2.0 to 4.0 mm in diameter planned for PCI with VIVO-ISAR (one or multiple stents).
•6.In case of multiple vessel disease all vessels must be treated with VIVO-ISAR
•7.No limitation on the number of treated lesions, vessels, and lesion length.

•1.Patients treated with stent other than study device
•2.Patients have other planned coronary vascular treatments after index procedure in same sitting.
•3.Patients unwilling or unable to comply with the postoperative visits necessary for data collection.
•4.Patient is pregnant or nursing an infant or child or planning to become pregnant while in the study
•5.Concurrent medical condition with a life expectancy of less than 3 years
•6.Patient is a recipient of heart transplant
•7.Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, sirolimus or similar drugs, or any other analogue or derivative, probucol, cobalt, chromium or contrast media
•8.Prior stenting in target or non-target vessel within 90 days before index procedure
•9.Patient participating in other study

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