Angioplasty or bypass surgery in intermittent claudication
| ISRCTN | ISRCTN39997806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39997806 |
| ClinicalTrials.gov number | NCT01177033 |
| Secondary identifying numbers | DRG. No. 222 |
- Submission date
- 09/05/2008
- Registration date
- 13/11/2008
- Last edited
- 12/06/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The build-up of fatty deposits (atherosclerotic lesions) on the walls of the superficial femoral artery, the main artery of the leg, may cause intermittent claudication, a painful ache in the legs when walking. In addition to medical treatment and walking exercise, restoration of the blood circulation (revascularization) is necessary in many patients. There are two main types of revascularisation. Angioplasty involves widening the artery by inflating a tiny balloon inside the vessel, and placing a short wire-mesh tube (stent) to allow the blood to flow more freely. Artery bypass graft involves taking a blood vessel from another part of the body and using it to bypass the blockage. The best method for lesions with a length of more than 10 cm and the possibility for an above-the-knee bypass is uncertain and is widely based on personal preference and institution policy rather than on evidence from studies. The aim of this study is to compare stent-protected balloon angioplasty with above-the-knee bypass surgery in patients with intermittent claudication.
Who can participate?
Patients with intermittent claudication caused by complex superficial femoral artery lesions with a length of more than 10 cm and the possibility for an above-knee bypass anastomosis.
What does the study involve?
Participants are randomly allocated to undergo either stent-protected balloon angioplasty or above-the-knee bypass surgery. All participants are followed up for 24 months to compare the proportion of surviving patients who show an improvement without the need for repeated revascularization or amputation.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Technische Universitaet Munchen (Germany)
When is the study starting and how long is it expected to run for?
July 2009 to April 2014
Who is funding the study?
1. German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)
2. Study Centre of the German Surgical Society (SDGC) (Germany)
Who is the main contact?
Prof. Hans-Henning Eckstein
Contact information
Scientific
Klinikum rechts der Isar
Technische Universitaet Munchen
Ismaninger Str. 22
Munich
81675
Germany
Study information
| Study design | Phase III randomised multicentre two-armed parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel 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 intermittent Claudication (ABC): a randomised controlled trial for patients with complex lesions of the superficial femoral artery |
| Study acronym | ABC |
| Study objectives | The objective of this study is to evaluate the safety and efficacy of two therapeutic strategies (operative versus endovascular) in the treatment of patients with complex atherosclerotic lesions of the superficial femoral artery (SFA). |
| Ethics approval(s) | Ethics approval pending from the Primary Ethics Committee in Munich as of 09/05/2008. The study should be approved after the funding by DFG is guaranteed. |
| Health condition(s) or problem(s) studied | Peripheral arterial occlusive disease (PAOD) |
| Intervention | Intervention type I: Best endovascular treatment (stent-protected angioplasty) Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available) Duration of intervention per patient: Dependant on the method of treatment Follow-up per patient: 24 months |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Clinical improvement of greater than one class without the need for repeated target lesion revascularisation (TLR) within 24 months in surviving patients as assessed by treadmill testing (3.2 km/h, 12% incline). |
| Secondary outcome measures | Clinical endpoints: 1. Periprocedural complications, in-hospital mortality, mortality and amputation rates within 24 months 2. Initial and absolute claudication distance after 12 and 24 months Procedural and morphological endpoints: 3. Greater than 50% restenosis of the target lesion or greater than 50% bypass stenosis 4. Repeated target lesion revascularisation (TLR) and repeated target extremity revascularisation (TER) within 24 months Haemodynamic endpoints: 5. Immediate and sustained ankle brachial index (ABI) improvement of greater than 0.15 during follow-up Further secondary endpoints: 6. Quality of life, assessed using 86-item disease-specific questionnaire (PAVK 86), 36-item Medical Outcome Study Short-Form Health Survey (MOS-SF 36) 7. Total costs of treatment modalities |
| Overall study start date | 01/07/2009 |
| Completion date | 01/04/2014 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 470 |
| Key inclusion criteria | 1. Intermittent claudication (IC) class 2 or 3 (Rutherford classification) as assessed by treadmill testing (3.2 km/h, 12% incline) lasting greater than three months caused by multiple stenoses or an occlusion of the SFA with a target lesion length of 10 - 20 cm 2. Failed conservative therapy and the desire of the patient for further treatment because he or she is either unable to perform normal work or has serious impairment of other important activities 3. Ankle brachial pressure index greater than 0.3 |
| Key exclusion criteria | 1. Greater than 50% stenosis or occlusion of the common and/or the deep femoral artery and the popliteal artery 2. Unsuitability of treadmill testing 3. Severe co-morbidities with a life expectancy of less than two years 4. Contraindications for antiplatelet agents and/or anticoagulants 5. Surgical or endovascular intervention on the index leg within the last six months |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 01/04/2014 |
Locations
Countries of recruitment
- Austria
- Germany
Study participating centre
81675
Germany
Sponsor information
University/education
c/o Prof. Dr. M. Schwaiger
Dean of the Medical Faculty
Ismaninger Str. 22
Munich
81675
Germany
| Website | http://portal.mytum.de/navigation_view |
|---|---|
"ROR" |
https://ror.org/02kkvpp62 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2011 | Yes | No |
Editorial Notes
12/06/2017: Plain English summary added.
31/01/2012: This study was stopped due to patient recruitment issues.
