NCT01177033

Angioplasty or Bypass Surgery in Intermittent Claudication

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 470 (estimated)
• Sponsor: Institut für Klinisch-Kardiovaskuläre Forschung GmbH · Network
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2014-12-01
• First posted: 2010-08-06
• Last updated: 2010-08-06

Locations

25 sites across 2 countries: Austria, Germany