Trials / Unknown
UnknownNCT00156611
Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease
ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease - A Randomized Prospective Trial (RIO-Trial)
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 420 (planned)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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 IIb/IIIa 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Balloon Angioplasty | |
| DRUG | ReoPro |
Timeline
- Start date
- 2002-01-01
- Completion
- 2009-12-01
- First posted
- 2005-09-12
- Last updated
- 2006-09-12
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00156611. Inclusion in this directory is not an endorsement.