Angioplasty or bypass surgery in intermittent claudicatio

Completed

• Conditions: Peripheral arterial occlusive disease (PAOD); Circulatory System; Other peripheral vascular diseases

• Registration Number: ISRCTN39997806
• Lead Sponsor: Munich Technical University (Technische Universitaet Munchen) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-13
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

1. Intermittent claudication (IC) class 2 or 3 (Rutherford classification) as assessed by treadmill testing (3.2 km/h, 12% incline) lasting greater than three months caused by multiple stenoses or an occlusion of the SFA with a target lesion length of 10 - 20 cm
2. Failed conservative therapy and the desire of the patient for further treatment because he or she is either unable to perform normal work or has serious impairment of other important activities
3. Ankle brachial pressure index greater than 0.3

Exclusion Criteria

1. Greater than 50% stenosis or occlusion of the common and/or the deep femoral artery and the popliteal artery
2. Unsuitability of treadmill testing
3. Severe co-morbidities with a life expectancy of less than two years
4. Contraindications for antiplatelet agents and/or anticoagulants
5. Surgical or endovascular intervention on the index leg within the last six months

Study & Design

• Study Type: Interventional
• Study Design: Not specified