Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease
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|ClinicalTrials.gov Identifier: NCT00156611|
Recruitment Status : Unknown
Verified September 2006 by University Hospital Tuebingen.
Recruitment status was: Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : September 12, 2006
|Condition or disease||Intervention/treatment||Phase|
|Arterial Occlusive Diseases||Procedure: Balloon Angioplasty Drug: ReoPro||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease – A Randomized Prospective Trial (RIO-Trial)|
|Study Start Date :||January 2002|
|Study Completion Date :||December 2009|
- Prevention of subacute occlusions within 30 days
- Prevention of restenosis up to 3 years
- Prevention of target lesion revascularization
- Improvement of the clinical status
- Change of ABI
- Hospital days
- all secondary outcomes at 30 days, 6 months, one year, and 3 years (telephone contact after 3 years)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156611
|University of Tuebingen|
|Tuebingen, Germany, 72076|
|Principal Investigator:||Gunnar Tepe, MD||University Hospital of Tuebingen|
|Principal Investigator:||Iris Baumgartner, MD||University of Bern|