Angioplasty or Bypass Surgery in Intermittent Claudication

NCT01177033 | Unknown DMC

• 2 other identifiers: ISRCTN 399978062010-021374-10
• Study Type: observational
• Target: 470
• Locations: 2 countries
• Sites: 25

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).

Conditions

Intermittent Claudication; Complex Lesions of the Superficial Femoral Artery

Study Arms (2)

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

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

Interventions

Best endovascular treatment or Best surgical treatment OTHER

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 endovascular treatment; Best surgical treatment

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Intermittent Claudication, due to complex lesions of the superficial femoral artery

You may qualify if:

• 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).

You may not qualify if:

• \>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

Sponsors & Collaborators

• Institut für Klinisch-Kardiovaskuläre Forschung GmbH: lead
• Technical University of Munich: collaborator

Study Sites (25)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

NOT YET RECRUITING

Wilhelminenhospital Wien

Vienna, 1160, Austria

NOT YET RECRUITING

Universitätsklinikum Aachen

Aachen, 52074, Germany

NOT YET RECRUITING

Klinikum Augsburg

Augsburg, 86156, Germany

NOT YET RECRUITING

Klinikum am Bruderwald

Bamberg, 96049, Germany

NOT YET RECRUITING

Bundeswehrkrankenhaus Berlin

Berlin, 10115, Germany

NOT YET RECRUITING

Uniklinik Bonn

Bonn, 53127, Germany

NOT YET RECRUITING

Klinikum und Fachbereich Medizin Johann Wolfgang Goethe Universität Frankfurt am Main

Frankfurt am Main, 60590, Germany

NOT YET RECRUITING

Universitätsherzzentrum / Klinik und Poliklinik für Gefäßmedizin

Hamburg, 20246, Germany

NOT YET RECRUITING

Klinikum Hanau

Hanau, 63450, Germany

NOT YET RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

NOT YET RECRUITING

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

NOT YET RECRUITING

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

NOT YET RECRUITING

Klinikum der Johannes Gutenberg Unviersität Mainz

Mainz, 55131, Germany

NOT YET RECRUITING

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

NOT YET RECRUITING

Evangelisches Krankenhaus Mühlheim

Mühlheim, 45468, Germany

NOT YET RECRUITING

Klinikum der Universität München, Chirurgische Klinik und Poliklinik Innenstadt

München, 80336, Germany

NOT YET RECRUITING

Klinikum Rechts der Isar, Technische Universität München

München, 81675, Germany

RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

NOT YET RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

NOT YET RECRUITING

Diakonissen-Stiftungs-Krankenhaus Speyer

Speyer, 67346, Germany

NOT YET RECRUITING

Katharinenhospital Stuttgart

Stuttgart, 70174, Germany

NOT YET RECRUITING

Universtitätsklinikum Ulm

Ulm, 89075, Germany

NOT YET RECRUITING

HSK Dr. Horst Schmidt Klinik

Wiesbaden, 65199, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2014
• Last Updated: August 6, 2010

Record last verified: 2010-05

Locations

AU (2); DE (23)