Angioplasty or bypass surgery in critical limb ischemia

ISRCTN	ISRCTN08459809
DOI	https://doi.org/10.1186/ISRCTN08459809
Secondary identifying numbers	DFG No. 247

Submission date: 25/05/2011
Registration date: 31/01/2012
Last edited: 31/01/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hans-Henning Eckstein
Scientific

Clinic for Vascular Surgery
Isar Hospital [Klinikum rechts der Isar]
Technische Universitaet Muenchen
Ismaninger Str. 22
Munich
81675
Germany

Study information

Study design	Open multi-centre randomised two-armed parallel group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2012
Completion 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 type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	550
Key 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
Key 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
Date of first enrolment	01/10/2012
Date of final enrolment	30/09/2016

Locations

Countries of recruitment

Germany

Study participating centre

Clinic for Vascular Surgery

Munich
81675
Germany

Sponsor information

Technical University of Munich [Technische Universitaet Muenchen] (Germany)
University/education

Klinikum rechts der Isar
Ismaninger Str. 22
Munich
81675
Germany

Website	http://portal.mytum.de/
"ROR"	https://ror.org/02kkvpp62

Funders

Funder type

Research organisation

German Research Foundation [Deutsche Forschungsgemeinschaft (DFG)] ref: 247

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan