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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01177033
Other study ID # ISRCTN 39997806
Secondary ID 2010-021374-10
Status Recruiting
Phase N/A
First received August 5, 2010
Last updated August 5, 2010
Start date August 2010
Est. completion date December 2014

Study information

Verified date May 2010
Source Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Contact n/a
Is FDA regulated No
Health authority Austria : Federal Ministry for Labour, Health, and Social AffairsAustria: Ethics CommissionGermany: Ethics Commission
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 470
Est. completion date December 2014
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 85 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Austria Medizinische Universität Innsbruck Innsbruck
Austria Wilhelminenhospital Wien Wien
Germany Universitätsklinikum Aachen Aachen
Germany Klinikum Augsburg Augsburg
Germany Klinikum am Bruderwald Bamberg
Germany Bundeswehrkrankenhaus Berlin Berlin
Germany Uniklinik Bonn Bonn
Germany Klinikum und Fachbereich Medizin Johann Wolfgang Goethe Universität Frankfurt am Main Frankfurt / Main
Germany Universitätsherzzentrum / Klinik und Poliklinik für Gefäßmedizin Hamburg
Germany Klinikum Hanau Hanau
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Klinikum Ingolstadt Ingolstadt
Germany Städtisches Klinikum Karlsruhe Karlsruhe
Germany Klinikum Ludwigsburg Ludwigsburg
Germany Klinikum der Johannes Gutenberg Unviersität Mainz Mainz
Germany Universitätsklinikum Mannheim Mannheim
Germany Evangelisches Krankenhaus Mühlheim Mühlheim
Germany Klinikum der Universität München, Chirurgische Klinik und Poliklinik Innenstadt München
Germany Klinikum Rechts der Isar, Technische Universität München München
Germany Universitätsklinikum Münster Münster
Germany Universitätsklinikum Regensburg Regensburg
Germany Diakonissen-Stiftungs-Krankenhaus Speyer Speyer
Germany Katharinenhospital Stuttgart Stuttgart
Germany Universtitätsklinikum Ulm Ulm
Germany HSK Dr. Horst Schmidt Klinik Wiesbaden

Sponsors (2)

Lead Sponsor Collaborator
Institut für Klinisch-Kardiovaskuläre Forschung GmbH Technische Universität München

Countries where clinical trial is conducted

Austria,  Germany, 

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