Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156611
Status:
UNKNOWN
Last Update Posted:
2006-09-12
First Post:
2005-09-07
Brief Title:
Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease - A Randomized Prospective Trial RIO-Trial
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
The Rio Study is a randomized double blinded German- Swiss- Austria multi-centre trial on the efficacy and safety of ReoPro together with interventional recanalization of TASC D lesions in the SFA and popliteal artery
Detailed Description:
Purpose The RIO trial is designed to test the efficacy of GP IIbIIIa blockade on subacute reocclusions in patients with interventional recanalization of chronic occlusions in the superficial femoral and popliteal artery
Methods A total of 420 patients will be randomly assigned to ReoPro or placebo Patients will be eligible for randomisation with occlusions longer than 5 cm Doppler ultrasound follow-up will be at 30 days and after 6 and 12 months
Methods A total of 420 patients will be randomly assigned to ReoPro or placebo Patients will be eligible for randomisation with occlusions longer than 5 cm Doppler ultrasound follow-up will be at 30 days and after 6 and 12 months
Study Oversight
Has Oversight DMC:
None
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?:
None