Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft. Multicenter Randomized Study of an Impregnated Knitted Polyester Prosthesis Vs. PTFE (Uni-Graft Vs Gore-Tex).

University Hospital, Gentofte, Copenhagen0 个研究点目标入组 400 人开始时间: 1993年10月1日最近更新: 2006年3月9日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 400
主要终点: Primary uncorrected graft patency after 2 years

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.

详细描述

Objective

To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.

排除标准

•pregnancy
•No consent to participate in the study
•Previous enrollment in the study
•follow-up is not possible

结局指标

主要结局

Primary uncorrected graft patency after 2 years

次要结局

- Secondary graft patency after two years
- Limb survival after two years
- Complication rate perioperatively

研究者

发起方

University Hospital, Gentofte, Copenhagen

申办方类型

Other

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