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

NCT ID: NCT00156611

Last Updated: 2006-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2009-12-31

Brief 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

Arterial Occlusive Diseases

Keywords

peripheral vascular disease; intervention; restenosis; Age above 18 years

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Balloon Angioplasty

Intervention Type: PROCEDURE

ReoPro

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Principal Investigators

Gunnar Tepe, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Tuebingen

Iris Baumgartner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

University of Tuebingen

Tübingen, , Germany

Countries

Germany

Other Identifiers

R-1

Identifier Type: -

Identifier Source: org_study_id