ISRCTN08459809
Completed
N/A
Angioplasty or bypass surgery in critical limb ischemia: a randomised controlled trial for patients with ischemic rest pain or tissue loss of the legs
Technical University of Munich [Technische Universitaet Muenchen] (Germany)0 sites550 target enrollmentJanuary 31, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Critical limb ischemia
- Sponsor
- Technical University of Munich [Technische Universitaet Muenchen] (Germany)
- Enrollment
- 550
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Critical limb ischemia (CLI) lasting \> 2 weeks (Fontaine stages III or IV or Rutherford classes 4 to 6 as assessed by clinical examination
- •2\. Ankle pressure \< 50 mm Hg, toe pressure \<30 mm Hg, TcPo2 \< 30 mm Hg
- •3\. Availability of adequate saphenous vein for bypass surgery
Exclusion Criteria
- •1\. Acute limb\-threatening ischemia (either embolic or thrombotic)
- •2\. Non\-atherosclerotic disease or documented hypercoagulopathy
- •3\. End\-stage renal disease and other severe co\-morbidities with a life expectancy of less than 2 years American Society of Anesthesiologists \[(ASA) IV, V]
- •4\. Chronic total occlusions of the common/superficial femoral artery (\>20cm) or the popliteal artery and proximal trifurcation vessels \[according to TransAtlantic InterSociety (TASC) II D lesions]
- •5\. Isolated single or multiple stenosis of the infrainguinal arteries that could be treated by endovascular means
- •6\. Impaired infow of the aorto\-iliac arteries (\>50% stenosis or occlusions)
- •7\. Contraindications for antiplatelet agents and/or anticoagulants
- •8\. Surgical or catheter intervention on the index leg within the last 3 months
Outcomes
Primary Outcomes
Not specified
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