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Angioplasty or Bypass Surgery in Intermittent Claudication

Conditions
Intermittent Claudication
Complex 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
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Best endovascular treatmentBest endovascular treatment or Best surgical treatmentIntervention 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 treatmentBest endovascular treatment or Best surgical treatmentIntervention 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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

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