Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients W… (NCT00156611) | Clinical Trial Compass
UnknownPhase 2/3
Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease
Germany420 participantsStarted 2002-01
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (tr…