Overview

This trial is active, not recruiting.

Condition arterial occlusive diseases
Treatments balloon angioplasty, reopro
Phase phase 2/phase 3
Sponsor University Hospital Tuebingen
Collaborator University of Bern
Start date January 2002
End date December 2009
Trial size 420 participants
Trial identifier NCT00156611, R-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
Prevention of subacute occlusions within 30 days
time frame:

Secondary Outcomes

Measure
Prevention of restenosis up to 3 years
time frame:
Prevention of target lesion revascularization
time frame:
Improvement of the clinical status
time frame:
Change of ABI
time frame:
Hospital days
time frame:
all secondary outcomes at 30 days, 6 months, one year, and 3 years (telephone contact after 3 years)
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease – A Randomized Prospective Trial (RIO-Trial)
Principal investigator Gunnar Tepe, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.