Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Hospital Tuebingen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University Hospital Tuebingen
Collaborator:
University of Bern
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00156611
First received: September 7, 2005
Last updated: September 11, 2006
Last verified: September 2006
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease – A Randomized Prospective Trial (RIO-Trial) |
Resource links provided by NLM:
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 |
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00156611 History of Changes |
| Other Study ID Numbers: | R-1 |
| Study First Received: | September 7, 2005 |
| Last Updated: | September 11, 2006 |
| 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 |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Atherosclerosis Arteriosclerosis |
Abciximab Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Anticoagulants |
ClinicalTrials.gov processed this record on May 23, 2013