Angioplasty or Bypass Surgery in Intermittent Claudication - Full Text View

Purpose

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).

Condition	Intervention
Intermittent Claudication Complex Lesions of the Superficial Femoral Artery	Other: Best endovascular treatment or Best surgical treatment

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Further study details as provided by Institut für Klinisch-Kardiovaskuläre Forschung GmbH:

Estimated Enrollment:	470
Study Start Date:	August 2010
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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).

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177033

Locations

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

Sponsors and Collaborators

Institut für Klinisch-Kardiovaskuläre Forschung GmbH

Technische Universität München

More Information

No publications provided

Responsible Party:	Univ.-Prof. Dr. Hans-Henning Eckstein, Klinikum Rechts der Isar, Technische Universität München
ClinicalTrials.gov Identifier:	NCT01177033 History of Changes
Other Study ID Numbers:	ISRCTN 39997806, 2010-021374-10
Study First Received:	August 5, 2010
Last Updated:	August 5, 2010
Health Authority:	Austria : Federal Ministry for Labour, Health, and Social Affairs Austria: Ethics Commission Germany: Ethics Commission

Additional relevant MeSH terms:

Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

Angioplasty or Bypass Surgery in Intermittent Claudication (ABC)