Angioplasty or Bypass Surgery in Intermittent Claudication

Intermittent Claudication Clinical Trial

— ABC  

Official title:

ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:

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

• Complex Lesions of the Superficial Femoral Artery
• Intermittent Claudication

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,