Clinical trial NCT00156611: Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease
Official title: ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease - A Randomized Prospective Trial (RIO-Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Arterial Occlusive Diseases
Keywords: peripheral vascular disease
intervention
restenosis
Age above 18 years
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2005-09-12
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Prevention of subacute occlusions within 30 days
Secondary outcomes:
measure: Prevention of restenosis up to 3 years
measure: Prevention of target lesion revascularization
measure: Improvement of the clinical status
measure: Change of ABI
measure: Hospital days
measure: all secondary outcomes at 30 days, 6 months, one year, and 3 years (telephone contact after 3 years)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen
Study officials:
affiliation: University Hospital of Tuebingen
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Iris Baumgartner, MD
role: PRINCIPAL_INVESTIGATOR
References: