Angioplasty or bypass surgery in critical limb ischemia

Angioplasty or bypass surgery in critical limb ischemia: a randomised controlled trial for patients with ischemic rest pain or tissue loss of the legs

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN08459809

Enrollment

550

Registered

2012-01-31

Start date

2012-10-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Critical limb ischemia Circulatory System Peripheral arterial disease

Interventions

As of 31/01/2012, this study was stopped due to patient recruitment issues. Intervention type I: Best endovascular treatment (angioplasty +/- stent) Intervention type II: Best surgical treatment (bel

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Perioperative death (POD, 30 days) 2. Any major adverse limb event (MALE) within 1 year 2.1. Above ankle amputation of the index limb 2.2. Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis)	—

Secondary

Measure	Time frame
1. Clinical safety endpoints 1.1. Major adverse cardiovascular event (MACE): myocardial infarction, stroke or death (any cause) within 30 days 1.2. Any MALE (definition see above) within 30 days 1.3. Above-ankle amputation within 30 days 2. Clinical efficacy endpoints 2.1. Any MALE (definition see above) within 2 years 2.2. Primary sustained clinical improvement: upward shift on the Rutherford or Fontaine classifcation to a level of intermittent claudication (IC) without the need for repeated target lesion revascularization (TLR) in surviving patients and without the need for unplanned amputation within 2 years 2.3. Secondary sustained clinical improvement: upward shift on the Rutherford or Fontaine classification to a level of IC including the need for repeated TLR in surviving patients and without the need for unplanned amputation within 2 years 2.4. Above ankle amputation of the index limb within 2 years 2.5. Amputation-Free Survival (AFS): above ankle amputation of the index limb or death (any cause) within 2 years 2.6. Any reintervention or above ankle amputation of the index limb within 2 years 2.7. Death (any cause) within 2 years 3. Haemodynamic endpoints (30 days, 3, 6, 12, 18, 24 months) 3.1. Failure to increase Ankle brachial Index (ABI) by at least 0.15 post-procedure as compared to baseline value 3.2. Decrease in ABI by 0.15 or greater as compared to post-procedure value 3.3. Duplex ultrasound or angiography demonstrating occlusion of graft or any treated vessel, or >50% stenosis in the presence or recurrent clinical symptoms 4. Further secondary endpoints 4.1. Wound healing documeted by serial photographs 4.2. Quality of life (PAVK 86, MOS-SF 36) 4.3. Total costs of treatment modalities	—

Measure

Time frame

1. Clinical safety endpoints 1.1. Major adverse cardiovascular event (MACE): myocardial infarction, stroke or death (any cause) within 30 days 1.2. Any MALE (definition see above) within 30 days 1.3. Above-ankle amputation within 30 days 2. Clinical efficacy endpoints 2.1. Any MALE (definition see above) within 2 years 2.2. Primary sustained clinical improvement: upward shift on the Rutherford or Fontaine classifcation to a level of intermittent claudication (IC) without the need for repeated target lesion revascularization (TLR) in surviving patients and without the need for unplanned amputation within 2 years 2.3. Secondary sustained clinical improvement: upward shift on the Rutherford or Fontaine classification to a level of IC including the need for repeated TLR in surviving patients and without the need for unplanned amputation within 2 years 2.4. Above ankle amputation of the index limb within 2 years 2.5. Amputation-Free Survival (AFS): above ankle amputation of the index limb or death (any cause) within 2 years 2.6. Any reintervention or above ankle amputation of the index limb within 2 years 2.7. Death (any cause) within 2 years 3. Haemodynamic endpoints (30 days, 3, 6, 12, 18, 24 months) 3.1. Failure to increase Ankle brachial Index (ABI) by at least 0.15 post-procedure as compared to baseline value 3.2. Decrease in ABI by 0.15 or greater as compared to post-procedure value 3.3. Duplex ultrasound or angiography demonstrating occlusion of graft or any treated vessel, or >50% stenosis in the presence or recurrent clinical symptoms 4. Further secondary endpoints 4.1. Wound healing documeted by serial photographs 4.2. Quality of life (PAVK 86, MOS-SF 36) 4.3. Total costs of treatment modalities

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Countries

Germany

Outcome results

None listed

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