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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Procedure: Balloon Angioplasty
* Drug: ReoPro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a history of peripheral artery disease with superficial femoral or popliteal artery occlusion, which mandates PTA or stent administration as first treatment modality. The history of peripheral artery occlusion has to be at least 6 weeks, and the target vessel occlusion has to be more than 5 centimeters in length. Age between 18 and 90 years Exclusion Criteria: Acute limb ischemia Subacute ischemia with requires thrombolysis as first treatment modality Active bleeding or known bleeding diathesis Known severe hepatic or renal disorder (liver cirrhosis, stage B, C or serum creatinine > 2.5 mg%) Hyperthyreosis Diabetes mellitus treated with metformin Known heparin induced thrombocytopenia (HIT, type 2) Female sex with childbearing potential Major surgery or trauma in past 6 weeks History of stroke within the previous 2 years, or any stroke with a residual neurological deficit, or other CNS abnormality (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm) Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks Administration of oral anticoagulants within the previous 7 days unless prothrombin time is < 1.2 times control (or international normalized ratio [INR] <1.4), or ongoing treatment with oral anticoagulants History of bleeding diathesis of platelet count < 100,000/mm3 Arteriovenous malformations or aneurysms Severe uncontrolled hypertension (treated sys. BP > 200 mm Hg, diast. BP > 100 mm Hg) Hypertensive or diabetic retinopathy Vasculitis Known autoimmune disorders Patient with aspirin intolerance Contraindication or known allergic reactions to abciximab or murine proteins Co-existent condition associated with a limited life expectancy (e.g., advanced cancer, end-stage congestive heart failure) Participation in another clinical research study involving the evaluation of another investigational drug or device within 7 days prior to enrollment Patient who has previously received a GP IIb/IIIa antagonist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Balloon Angioplasty|nan|
|Drug: ReoPro|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of subacute occlusions within 30 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral vascular disease, intervention, restenosis, Age above 18 years