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Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease

Arterial Occlusive Diseases Clinical Trial

Official title:
ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease – A Randomized Prospective Trial (RIO-Trial)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00156611
Study type Interventional
Source University Hospital Tuebingen
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date January 2002
Completion date December 2009
View Details
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