Metalless PCI Registry - A prospective, single-arm, single-centre registry to evaluate safety and performance of Bioresorbable Vascular Scaffold along with drug-eluting balloon in patients with long diffused de-novo coronary lesions.

il0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

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•1.Patients aged greaterthan equal to 18 years.
•2.Patients with long diffused de-novo coronary lesions greaterthan 25 mm suitable for treatment with BRS along with drug eluting balloon.3.Patient has given written informed consent for participation prior to enrolment.4.Patient is willing to undergo all study procedures and follow-up requirements.

•1.Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin, ticlopidine, prasugrel, ticagrelor and drug such as Sirolimus Rapamycin or similar drugs or any analogue or derivative, poly L lactide PLLA, poly DL lactide PDLLA, platinum, or with any contrast media.2.Patient in whom antiplatelet and or anti coagulant therapy are contraindicated.3.Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon.4.Transplant patient. 5.Patients with low ejection fraction Lessthan30percentage
•6.Renal insufficiency where creatinine levels are more than 1.3 mg per dl 7.Patients with vascular aneurysms 8.Lesion located in left main coronary artery 9.Aorto ostial location within 3 mm
•10.Patients with Chronic Total Occlusions
•11.Patients with bifurcation or trifurcation lesion disease or multivessel complex lesions
•12.Patients with severely calcified vessels and angulations 13.Subject is high risk of bleeding for any reason.14.Pregnant or lactating female.
•15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study.

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