Condition category
Circulatory System
Date applied
25/05/2011
Date assigned
31/01/2012
Last edited
31/01/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hans-Henning Eckstein

ORCID ID

Contact details

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

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 measures

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

"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

http://portal.mytum.de/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes