Angioplasty or Bypass Surgery in Intermittent Claudication (ABC)

ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:

CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS

Phase: IV

TITLE OF STUDY

Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery

CONDITION

Peripheral arterial occlusive disease (PAOD)

OBJECTIVE(S)

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.

INTERVENTIONS

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: Dependent on the method of treatment

Follow-up per patient: 24 months

OUTCOMES

Primary efficacy endpoint:

Two primary efficacy endpoints will be considered simultaneously in this trial:

(A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR).

(B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford classification) at 24 months after primary intervention (regardless any performed re-intervention).

Study Overview

• Status: Unknown
• Conditions: Intermittent Claudication; Complex Lesions of the Superficial Femoral Artery
• Intervention / Treatment: Other: Best endovascular treatment or Best surgical treatment

• Study Type: Observational
• Enrollment (Anticipated): 470

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Not yet recruiting
    • Medizinische Universität Innsbruck
    • Contact: Gustav Fraedrich, Prof. Dr.; Phone Number: +43 050 50422587; Email: Gustav.Fraedrich@i-med.ac.at
  • Wien, Austria, 1160
    • Not yet recruiting
    • Wilhelminenhospital Wien
    • Contact: Afshin Assadian, PD Dr; Phone Number: +43149150-4101; Email: wil1chsek@wienkav.at
• Germany
  • Aachen, Germany, 52074
    • Not yet recruiting
    • Universitätsklinikum Aachen
    • Contact: M. Jacobs, Prof. Dr.; Phone Number: +49-241-8080832; Email: mjacobs@ukaachen.de
  • Augsburg, Germany, 86156
    • Not yet recruiting
    • Klinikum Augsburg
    • Contact: Klaus Wölfle, Prof. Dr.; Phone Number: +49-821-4002655; Email: klaus.woelfle@klinikum-augsburg.de
  • Bamberg, Germany, 96049
    • Not yet recruiting
    • Klinikum am Bruderwald
    • Contact: Heinz Weber, Dr.; Phone Number: +49951-50312151; Email: heinz.weber@sozialstiftung-bamberg.de
  • Berlin, Germany, 10115
    • Not yet recruiting
    • Bundeswehrkrankenhaus Berlin
    • Contact: Malte Hegenscheid, Dr.; Phone Number: +493028411291; Email: maltehegenscheid@bundeswehr.org
  • Bonn, Germany, 53127
    • Not yet recruiting
    • Uniklinik Bonn
    • Contact: Frauke Verrel, Dr.; Phone Number: +49 22828715109; Email: frauke.verrel@ukb.uni-bonn.de
  • Frankfurt / Main, Germany, 60590
    • Not yet recruiting
    • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe Universität Frankfurt am Main
    • Contact: Schmitz-Rixen, Prof. Dr.; Phone Number: +49 6963015349; Email: schmitz-rixen@em.uni-frankfurt.de
  • Hamburg, Germany, 20246
    • Not yet recruiting
    • Universitätsherzzentrum / Klinik und Poliklinik für Gefäßmedizin
    • Contact: S. Debus, Prof. Dr.; Phone Number: +4940-741053876; Email: debus@uke.de
  • Hanau, Germany, 63450
    • Not yet recruiting
    • Klinikum Hanau
    • Contact: Hardy Schumacher, Prof. Dr.; Phone Number: +49-6181-2962310; Email: hardy_schumacher@klinikum-hanau.de
  • Heidelberg, Germany, 69120
    • Not yet recruiting
    • Universitätsklinikum Heidelberg
    • Contact: Dittmar Böckler, Prof. Dr.; Phone Number: +49 6221 - 566110; Email: dittmar.boeckler@med.uni-heidelberg.de
  • Ingolstadt, Germany, 85049
    • Not yet recruiting
    • Klinikum Ingolstadt
    • Contact: Volker Ruppert, PD Dr; Phone Number: +49 841-8802425; Email: volker.ruppert@klinikum-ingolstadt.de
  • Karlsruhe, Germany, 76133
    • Not yet recruiting
    • Städtisches Klinikum Karlsruhe
    • Contact: Martin Storck, Prof. Dr.; Phone Number: +49721-9742301; Email: martin.storck@klinikum-karlsruhe.de
  • Ludwigsburg, Germany, 71640
    • Not yet recruiting
    • Klinikum Ludwigsburg
    • Contact: Johannes Gahlen, Prof.Dr; Phone Number: +49 7141-9966401; Email: johannes.gahlen@kliniken-lb.de
  • Mainz, Germany, 55131
    • Not yet recruiting
    • Klinikum der Johannes Gutenberg Unviersität Mainz
    • Contact: Christoph Düber, Prof.Dr; Phone Number: +49 6131-173208; Email: dueber@radiologie.klinik.uni-mainz.de
  • Mannheim, Germany, 68167
    • Not yet recruiting
    • Universitätsklinikum Mannheim
    • Contact: M. Niedergethmann, Prof. Dr.
  • Mühlheim, Germany, 45468
    • Not yet recruiting
    • Evangelisches Krankenhaus Mühlheim
    • Contact: Alexander Stehr, PD Dr.; Phone Number: +49 - 208 - 3092440; Email: Alexander.Stehr@evkmh.de
  • München, Germany, 80336
    • Not yet recruiting
    • Klinikum der Universität München, Chirurgische Klinik und Poliklinik Innenstadt
    • Contact: Ulrich Hoffmann, Prof. Dr.; Phone Number: +49 89 51603601; Email: Ulrich.Hoffmann@med.uni-muenchen.de
  • München, Germany, 81675
    • Recruiting
    • Klinikum Rechts der Isar, Technische Universität München
    • Contact: Hans-Henning Eckstein, Prof. Dr.; Phone Number: +49-89-41402167; Email: H.H.Eckstein@lrz.tum.de
  • Münster, Germany, 48149
    • Not yet recruiting
    • Universitätsklinikum Münster
    • Contact: Giovanni Torsello, Prof. Dr.; Phone Number: +49251-8345782; Email: Giovanni.Torsello@ukmuenster.de
  • Regensburg, Germany, 93053
    • Not yet recruiting
    • Universitätsklinikum Regensburg
    • Contact: Piotr Kasprzak, PD Dr.; Phone Number: +49 941-9446911; Email: piotr.kasprzak@klinik.uni-regensburg.de
  • Speyer, Germany, 67346
    • Not yet recruiting
    • Diakonissen-Stiftungs-Krankenhaus Speyer
    • Contact: Gerhard Rümenapf, Prof. Dr.; Phone Number: +49 - 6232-221955; Email: gerhard.ruemenapf@diakonissen-speyer.de
  • Stuttgart, Germany, 70174
    • Not yet recruiting
    • Katharinenhospital Stuttgart
    • Contact: Thomas Hupp, Prof.Dr.; Phone Number: +49711-27833601; Email: t.hupp@klinikum-stuttgart.de
  • Ulm, Germany, 89075
    • Not yet recruiting
    • Universtitätsklinikum Ulm
    • Contact: Karl-Heinz Orend, Prof. Dr.; Phone Number: +49-731-500544001; Email: karl-heinz.orend@uniklinik-ulm.de
  • Wiesbaden, Germany, 65199
    • Not yet recruiting
    • HSK Dr. Horst Schmidt Klinik
    • Contact: Achim Neufang, PD Dr.; Email: achim.neufang@hsk-wiesbaden.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Intermittent Claudication, due to complex lesions of the superficial femoral artery

Description

Inclusion Criteria:

• Patient is able to verbally acknowledge and understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.
• Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol.
• Age ≥ 50 and ≤ 85 years old.
• Intermittent claudication (IC) class 2 or 3 (Rutherford) assessed by treadmill testing or 6-Minute Walk Test.
• Lasting >3 months.
• Failed conservative therapy and the patient's desire for further treatment.
• Atherosclerotic single or multiple stenoses (>50%) or an occlusion of the Superficial Femoral Artery (SFA) with a target lesion length of 10-20 cm without involvement of the common/deep femoral artery and/or the popliteal artery confirmed by duplex ultrasound and angiography.
• At least one patent tibioperoneal artery with no stenosis >50% in diameter. Technical and morphological accessibility for both catheter intervention and bypass surgery.
• Absence of other disease that would limit exercise (e.g. angina or chronic respiratory disease).

Exclusion Criteria:

• >50% stenosis or occlusion of the iliac, the common, the deep femoral or the popliteal artery.
• Surgical reconstruction or catheter intervention on the index leg within the last six months.
• Unsuitability of treadmill testing / Six-Minute Walk Test. Chronic limb ischemia (intermittent claudication class 2 to 6) on the contralateral leg.
• Known allergy to contrast agents containing iodine.
• Contraindication for antiplatelet agents or anticoagulants.
• Clinically manifested heart insufficiency (NYHA III, IV) and/or uncorrected hyperthyreosis.
• Serious general disease state with an estimated life expectancy < 2 years (ASA IV, V).
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Best endovascular treatment; 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).	Other: Best endovascular treatment or Best surgical treatment; 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).
Best surgical treatment; 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).	Other: Best endovascular treatment or Best surgical treatment; 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).

Collaborators and Investigators

• Sponsor: Institut für Klinisch-Kardiovaskuläre Forschung GmbH
• Collaborators: Technical University of Munich

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Estimate): August 6, 2010
• Last Update Submitted That Met QC Criteria: August 5, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intermittent Claudication
• Other Study ID Numbers: ISRCTN 39997806; 2010-021374-10 (EudraCT Number)