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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
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014