ISRCTN08459809CompletedNot Applicable
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 enrollmentStarted: January 31, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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