Angioplasty or Bypass Surgery in Intermittent Claudication
- Conditions
- Intermittent ClaudicationComplex Lesions of the Superficial Femoral Artery
- Interventions
- Other: Best endovascular treatment or Best surgical treatment
- Registration Number
- NCT01177033
- Lead Sponsor
- Institut für Klinisch-Kardiovaskuläre Forschung GmbH
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 470
- 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).
- >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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Best endovascular treatment 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 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).
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe Universität Frankfurt am Main
🇩🇪Frankfurt / Main, Germany
Klinikum Rechts der Isar, Technische Universität München
🇩🇪München, Germany
Uniklinik Bonn
🇩🇪Bonn, Germany
Klinikum Hanau
🇩🇪Hanau, Germany
Klinikum am Bruderwald
🇩🇪Bamberg, Germany
Universitätsherzzentrum / Klinik und Poliklinik für Gefäßmedizin
🇩🇪Hamburg, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
Klinikum Ingolstadt
🇩🇪Ingolstadt, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, 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
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Katharinenhospital Stuttgart
🇩🇪Stuttgart, Germany
Universtitätsklinikum Ulm
🇩🇪Ulm, Germany
Bundeswehrkrankenhaus Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
🇩🇪Speyer, Germany
HSK Dr. Horst Schmidt Klinik
🇩🇪Wiesbaden, Germany
Wilhelminenhospital Wien
🇦🇹Wien, Austria
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria