Condition category
Circulatory System
Date applied
09/05/2008
Date assigned
13/11/2008
Last edited
12/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hans-Henning Eckstein

ORCID ID

Contact details

Klinikum rechts der Isar
Technische Universitaet Munchen
Ismaninger Str. 22
Munich
81675
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01177033

Protocol/serial number

DRG. No. 222

Study information

Scientific title

Angioplasty or Bypass surgery in intermittent Claudication (ABC): a randomised controlled trial for patients with complex lesions of the superficial femoral artery

Acronym

ABC

Study hypothesis

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

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.

Study design

Phase III randomised multicentre two-armed parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel 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

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/07/2009

Overall trial end date

01/04/2014

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

470

Participant 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

Recruitment start date

01/07/2009

Recruitment end date

01/04/2014

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

Technische Universitaet Munchen
Munich
81675
Germany

Sponsor information

Organisation

Munich Technical University (Technische Universitaet Munchen) (Germany)

Sponsor details

c/o Prof. Dr. M. Schwaiger
Dean of the Medical Faculty
Ismaninger Str. 22
Munich
81675
Germany

Sponsor type

University/education

Website

http://portal.mytum.de/navigation_view

Funders

Funder type

Research organisation

Funder name

Deutsche Forschungsgemeinschaft

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Funder name

Study Centre of the German Surgical Society (SDGC) (Germany)

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21795079

Publication citations

  1. Protocol

    Zimmermann A, Berger H, Ulm K, Hoffmann U, Assadian A, Wildgruber M, Eckstein HH, , WITHDRAWN: Rationale and Design of a Randomised Controlled Trial Comparing Stent-Protected Angioplasty with Bypass Surgery for Intermittent Claudication: The ABC Study., Eur J Vasc Endovasc Surg, 2011, doi: 10.1016/j.ejvs.2011.06.051.

Additional files

Editorial Notes

12/06/2017: Plain English summary added. 31/01/2012: This study was stopped due to patient recruitment issues.