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Angioplasty or Bypass Surgery in Intermittent Claudication (ABC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2010 by Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Institut für Klinisch-Kardiovaskuläre Forschung GmbH
ClinicalTrials.gov Identifier:
NCT01177033
First received: August 5, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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   
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   
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
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014