Dedicated Branch Stent vs Conventional Stent in Bifurcation Coronary stenosis -A medium term followup

ESIC Super Speciality Hospital0 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

试验速览

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•1.The patientmustbegreaterthan euqal 18 years of age.2.True coronary bifurcation greaterthan equal to 50 percentage diameter stenosis in both the main and side branches, belonging to the Medina classes 1,1,1 or 1,0,1 or 0,1,1.3.Patients with de novo bifurcation lesions in native coronary arteries with reference diameter ranging from 2.5 mm to 3.5 mm in the side branch and 2.5 mm to 4.0 mm in main branch4.Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure.
•5.The patient is willing to comply with protocol specified follow-up evaluations.6.Patient or his or her legally authorized representative if applicable agrees to provide written informed consent as approved by respective Ethics Committee and applicable regulatory authorities.

•1.Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus Rapamycin or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media.2.Patients in whom anti-platelet and or anticoagulant therapy are contraindicated. 3.Angiographic evidence of thrombus.4.Direct stenting of the left main bifurcation 5.Impaired runoff in the treatment vessel with diffuse distal disease.6.A significant greaterthan 50 percentage stenosis proximal to distal to the target lesion.
•7.Ejection fraction lessthan 30 percentage 8.Patient requiring anticipated rotational atherectomy as per the Investigators judgement.
•9.Highly calcified lesions in which full stent dilatation may not be possible.10.Patients with totally occluded vessel.11.Target lesion has excessive tortuosity unsuitable for stent delivery and deployment. 12.Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon. 13.Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant. 14.Pregnant or nursing patients or those who plan pregnancy during study period 15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study

发起方

ESIC Super Speciality Hospital