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临床试验/NCT00566436
NCT00566436Unknown不适用

The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery

St. Antonius Hospital8 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
126
试验地点
8
主要终点
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass

研究概览

简要总结

The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.

详细描述

Different strategies exist in the treatment of chronic long occlusions of the superficial femoral artery and yet we still suffer a significant percentage of restenosis, re-occlusions and even major amputations, reason for continuous development of new techniques. One such technique is the recently developed minimal invasive remote endarterectomy, which shows promising patency rates and possibly less complications with earlier recovery. A more experienced and the most implemented technique is the suprageniculate femoropopliteal bypass graft, which, when using the saphenous vein, has proved durable. A randomized trial comparing both modalities was lacking so far, what makes the objective of this study a comparison of patency rates between those 2 techniques in a randomized fashion.

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
None

入排标准

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

入选标准

  • Patients presenting with Fontaine IIB, III, IV ischemia
  • Long (>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel
  • Atherosclerotic disease

排除标准

  • Previous operations on the superficial femoral artery
  • Radiation therapy groin/leg region
  • Diameter superficial femoral artery < 4 mm
  • Contrast allergy

结局指标

主要结局

(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass

时间窗: 5 year

次要结局

  • (a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out(5 year)
  • major amputation of the ipsilateral leg(5 year)

研究者

申办方类型
Other

研究点 (8)

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