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