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| [ ...Back to search results ] | [ Print-friendly version ] |
| Angioplasty or bypass surgery in critical limb ischemia |
| ISRCTN | ISRCTN08459809 |
| ClinicalTrials.gov identifier | |
| Public title | Angioplasty or bypass surgery in critical limb ischemia |
| Scientific title | Angioplasty or bypass surgery in critical limb ischemia: a randomised controlled trial for patients with ischemic rest pain or tissue loss of the legs |
| Acronym | N/A |
| Serial number at source | DFG No. 247 |
| Study hypothesis | Endovascular treatment is not inferior as compared to operative treatment in patients with ischemic rest pain or tissue loss of the legs (consistent to Fontaine stages III or IV and Rutherford classes 4 to 6) |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Open multi-centre randomised two-armed parallel group study |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Critical limb ischemia |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2012 |
| Anticipated end date | 30/09/2016 |
| Status of trial | Stopped |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 550 |
| 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 (below the knee vein bypass) |
| Primary outcome measure(s) |
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 outcome measure(s) |
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 |
| Sources of funding | German Research Foundation [Deutsche Forschungsgemeinschaft (DFG)] ref: 247 |
| Trial website | |
| Publications | |
| Contact name | Prof Hans-Henning Eckstein |
| Address |
Clinic for Vascular Surgery
Isar Hospital [Klinikum rechts der Isar] Technische Universitaet Muenchen Ismaninger Str. 22 |
| City/town | Munich |
| Zip/Postcode | 81675 |
| Country | Germany |
| Sponsor | Technical University of Munich [Technische Universitaet Muenchen] (Germany) |
| Address |
Klinikum rechts der Isar
Ismaninger Str. 22 |
| City/town | Munich |
| Zip/Postcode | 81675 |
| Country | Germany |
| Sponsor website: | http://portal.mytum.de/ |
| Date applied | 25/05/2011 |
| Last edited | 31/01/2012 |
| Date ISRCTN assigned | 31/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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