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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00156611
• Other study ID #: R-1
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 7, 2005
• Last updated: September 11, 2006
• Start date: January 2002
• Est. completion date: December 2009

Study information

• Verified date: September 2006
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Balloon Angioplasty

Drug:
• ReoPro

Locations

Country	Name	City	State
Germany	University of Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	University of Bern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of subacute occlusions within 30 days
Secondary	Prevention of restenosis up to 3 years
Secondary	Prevention of target lesion revascularization
Secondary	Improvement of the clinical status
Secondary	Change of ABI
Secondary	Hospital days
Secondary	all secondary outcomes at 30 days, 6 months, one year, and 3 years (telephone contact after 3 years)