Angioplasty or bypass surgery in critical limb ischemia

Completed

• Conditions: Critical limb ischemia; Circulatory System; Peripheral arterial disease

• Registration Number: ISRCTN08459809
• Lead Sponsor: Technical University of Munich [Technische Universitaet Muenchen] (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified