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

Sponsors and Collaborators:	University Hospital Tuebingen University of Bern
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00156611

Purpose

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.

Condition	Intervention	Phase
Arterial Occlusive Diseases	Procedure: Balloon Angioplasty Drug: ReoPro	Phase II Phase III

MedlinePlus related topics: Angioplasty Vascular Diseases

Drug Information available for: Abciximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease – A Randomized Prospective Trial (RIO-Trial)

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Prevention of subacute occlusions within 30 days

Secondary Outcome Measures:

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

Estimated Enrollment:	420
Study Start Date:	January 2002
Estimated Study Completion Date:	December 2009

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156611

Locations

Germany
University of Tuebingen
Tuebingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

University of Bern

Investigators

Principal Investigator:	Gunnar Tepe, MD	University Hospital of Tuebingen
Principal Investigator:	Iris Baumgartner, MD	University of Bern

More Information

Study ID Numbers:	R-1
Study First Received:	September 7, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00156611
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

peripheral vascular disease
intervention
restenosis
Age above 18 years

Study placed in the following topic categories:

Arterial Occlusive Diseases
Peripheral Vascular Diseases
Vascular Diseases
Abciximab

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009