Clinical trial NCT01177033: Angioplasty or Bypass Surgery in Intermittent Claudication
Official title: ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intermittent Claudication
Complex Lesions of the Superficial Femoral Artery
Lead sponsor: Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Sponsor class: NETWORK
Collaborators: name: Technical University of Munich
First posted: 2010-08-06
Enrollment: 470
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Intermittent Claudication, due to complex lesions of the superficial femoral artery

Brief 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).


Eligibility 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

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