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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
420
University of Tuebingen
Tübingen, Germany
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)
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