CTRI/2024/12/078769招募中Unknown
Comparison of the efficacy, safety & patency of combined Directional Atherectomy with Drug-Coated Balloon Angioplasty versus combined Directional Atherectomy with Vascular mimetic Stent placement for the treatment of femoropopliteal atherosclerotic Peripheral Vascular Disease- A Randomized Controlled Trial
Department of Interventional Radiology KLES Prabhakar Kore Hospital and MRC1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年1月15日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Technical success, Net luminal gain, Primary patency rate
研究概览
简要总结
Through this single centre prospective randomized parallel group open label study, we aim to compare the efficacy, safety and patency rates of combined directional atherectomy with drug-coated balloon angioplasty (DCB) versus combined directional atherectomy with vascular mimetic stent placement for treatment of lower limb peripheral arterial disease involving the superficial femoral and popliteal arteries.
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
- Male
入选标准
- •Patients with symptomatic chronic lower limb ischemia (Rutherford category 2 to 6) with lifestyle-limiting symptoms such as claudication pain, ischemic rest pain, ischemic ulceration, or gangrene.
- •Imaging (CT / MR angiography) evidence of ≥70% stenosis, or occlusion of the superficial femoral (SFA) or popliteal artery (PA).
- •Preserved distal perfusion of foot via at least one below knee vessel or collaterals.
排除标准
- •Clinical or imaging (Duplex ultrasound/CT/MR/DSA angiography) evidence of acute limb ischemia.
- •Previous history of endovascular intervention or bypass surgery of the target limb.
- •Contraindication to antiplatelet therapy, anticoagulants, or any other medication that is planned to be administered.
- •Known hypersensitivity to treatment device material or iodinated contrast agents, that cannot be sufficiently pre-treated.
- •End-stage renal disease.
结局指标
主要结局
Technical success, Net luminal gain, Primary patency rate
时间窗: One day, Six months, One year
次要结局
- Complication rate(One day, Six months, One year)
研究者
Satyam Barchha
JAWAHARLAL NEHRU MEDICAL COLLEGE, KLES UNIVERSITY
研究点 (1)
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