Condition category
Circulatory System
Date applied
09/05/2008
Date assigned
13/11/2008
Last edited
02/08/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Lay summary under review 3

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 Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery

Acronym

ABC Trial

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

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

Peripheral arterial occlusive disease (PAOD)

Intervention

As of 31/01/2012, this study was stopped due to patient recruitment issues.

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

Other

Phase

Phase III

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 (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": lack of recruitment of participants

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

Klinikum rechts der Isar
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

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 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