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Clinical Trials/ISRCTN39997806
ISRCTN39997806CompletedNot Applicable

Angioplasty or Bypass surgery in intermittent Claudication (ABC): a randomised controlled trial for patients with complex lesions of the superficial femoral artery

Munich Technical University (Technische Universitaet Munchen) (Germany)0 sites470 target enrollmentStarted: November 13, 2008Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
470

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
Munich Technical University (Technische Universitaet Munchen) (Germany)

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