Intermittent Claudication Clinical Trial
Official title:
ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:
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).
n/a
Observational Model: Cohort, Time Perspective: Prospective
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