Comparison of outcomes of drug coated balloon angioplasty and plain old balloon angioplasty of ostial coronary lesions

VMMC and Safdarjung hospital1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2024年7月10日最近更新: 2024年6月28日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: Angiographic outcomes:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Thus study is a randomized parallel group trial comparing Drug coated balloon (DCB) angioplasty and Plain Old Balloon Angioplasty (POBA) for ostial coronary lesions. This study will be conducted in Department of Cardiology, VMMC and Safdarjung Hospital, New Delhi. 60 patients undergoing PCI with intention to use balloon only strategy for de novo side branch ostial lesion (Medina 0,0,1) meeting inclusion criteria will be included. The patients will be followed up after a period of 6 months. Primary (angiographic) and secondary (clinical) outcomes will be assessed at follow-up.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Stable angina with documented ischemia or typical symptoms with ECG changes or Unstable angina
•Eligible for PCI with the intention to use balloon only strategy for de novo side branch ostial lesion (Medina classification 0,0,1)
•Side branch with diameter greater than 2.0mm.

排除标准

•Left main bifurcation except isolated ostial LCX lesion.
•If angioplasty of any other lesion is required/ performed with study procedure.
•Severely calcified lesions
•Contraindications to DAPT
•History of hypersensitivity to contrast
•Prior stenting in target vessel.