Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DFG No. 247
Study information
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
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)
Ethics approval
Not provided at time of registration
Study design
Open multi-centre randomised two-armed parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Critical limb ischemia
Intervention
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)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/10/2012
Overall trial end date
30/09/2016
Reason abandoned (if study stopped)
"Participant recruitment issue": lack of recruitment of participants in previous phase of trial ISRCTN39997806, so this study was not started
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
550
Participant 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
Recruitment start date
01/10/2012
Recruitment end date
30/09/2016
Locations
Countries of recruitment
Germany
Trial participating centre
Clinic for Vascular Surgery
Munich
81675
Germany
Sponsor information
Organisation
Technical University of Munich [Technische Universitaet Muenchen] (Germany)
Sponsor details
Klinikum rechts der Isar
Ismaninger Str. 22
Munich
81675
Germany
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
German Research Foundation [Deutsche Forschungsgemeinschaft (DFG)] ref: 247
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list