Angioplasty or bypass surgery in intermittent claudication

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39997806

Enrollment

470

Registered

2008-11-13

Start date

2009-07-01

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial occlusive disease (PAOD) Circulatory System Other peripheral vascular diseases

Interventions

Intervention type I: Best endovascular treatment (stent-protected angioplasty) Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Clinical improvement of greater than one class without the need for repeated target lesion revascularisation (TLR) within 24 months in surviving patients as assessed by treadmill testing (3.2 km/h, 12% incline).	—

Secondary

Measure	Time frame
Clinical endpoints: 1. Periprocedural complications, in-hospital mortality, mortality and amputation rates within 24 months 2. Initial and absolute claudication distance after 12 and 24 months Procedural and morphological endpoints: 3. Greater than 50% restenosis of the target lesion or greater than 50% bypass stenosis 4. Repeated target lesion revascularisation (TLR) and repeated target extremity revascularisation (TER) within 24 months Haemodynamic endpoints: 5. Immediate and sustained ankle brachial index (ABI) improvement of greater than 0.15 during follow-up Further secondary endpoints: 6. Quality of life, assessed using 86-item disease-specific questionnaire (PAVK 86), 36-item Medical Outcome Study Short-Form Health Survey (MOS-SF 36) 7. Total costs of treatment modalities	—

Measure

Time frame

Clinical endpoints: 1. Periprocedural complications, in-hospital mortality, mortality and amputation rates within 24 months 2. Initial and absolute claudication distance after 12 and 24 months Procedural and morphological endpoints: 3. Greater than 50% restenosis of the target lesion or greater than 50% bypass stenosis 4. Repeated target lesion revascularisation (TLR) and repeated target extremity revascularisation (TER) within 24 months Haemodynamic endpoints: 5. Immediate and sustained ankle brachial index (ABI) improvement of greater than 0.15 during follow-up Further secondary endpoints: 6. Quality of life, assessed using 86-item disease-specific questionnaire (PAVK 86), 36-item Medical Outcome Study Short-Form Health Survey (MOS-SF 36) 7. Total costs of treatment modalities

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Countries

Austria, Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026