Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-30 @ 4:40 PM
Study NCT ID:
NCT01177033
Status:
UNKNOWN
Last Update Posted:
2010-08-06
First Post:
2010-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angioplasty or Bypass Surgery in Intermittent Claudication
Sponsor:
Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Organization:
Study Overview
Official Title:
ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:
Status:
UNKNOWN
Status Verified Date:
2010-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABC
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 (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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-021374-10 | EUDRACT_NUMBER | None | View |