Clinical Trial: Angioplasty or Bypass Surgery in Intermittent Claudication

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

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 (Ruther

Detailed Summary:
Sponsor: Institut für Klinisch-Kardiovaskuläre Forschung GmbH

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Institut für Klinisch-Kardiovaskuläre Forschung GmbH

Dates:
Date Received: August 5, 2010
Date Started: August 2010
Date Completion: December 2014
Last Updated: August 5, 2010
Last Verified: May 2010