A Prospective Trail Comparing Safety and Efficacy of Collagen based vs Suture based Vascular Closure Device and Manual Compression in Patients who have Undergone Femoral Artery Puncture Interventional Procedure

Rohit Walia1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2020年5月31日最近更新: 2021年10月18日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Rohit Walia
入组人数: 200
试验地点: 1
主要终点: Time to Haemostasis

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

The project compares various vascular closure devices available for safety and efficacy in femoral artery puncture intervention procedures. Collagen based vascular closure devices and suture based will be used and compared in terms of time to hemostasis , time to ambulation and safety profile and various complications. ultrasound evaluation of he puncture site will also be done at baseline , post deployment and at six months.

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, variable
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Age greater than 18 years , valid informed consent , posted for femoral artery puncture based diagnostic or interventional procedure.

排除标准

•vascular graft or a re-puncture at a site previously punctured within 48 hours or planned arterial access at the same access site within 30 days of catheterisation bleeding disorder , significant anemia allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polylactic acid polymers.
•Patients undergoing thrombolytic therapy or treated with Warfarin within 24 hours prior to catheterization.
•Patients who are known or suspected to be pregnant or is lactating.
•Patients with uncontrolled hypertension with systolic blood pressure greater than 180 mmHg, unless systolic pressure can be lowered by pharmacological agents prior to closure.
•Peripheral vascular disease.

结局指标

主要结局

Time to Haemostasis

时间窗: Time to Haemostasis

次要结局

Time to ambulation, patient satisfaction, and vascular complications are secondary endpoints.(Day 2)

研究者

发起方

Rohit Walia

申办方类型

Other [Principal Investigator ]

研究点 (1)

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