ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00156611
Recruitment Status : Unknown
Verified September 2006 by University Hospital Tuebingen.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : September 12, 2006
Sponsor:
Collaborator:
University of Bern
Information provided by:
University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Procedure: Balloon Angioplasty Drug: ReoPro Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : January 2002
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Abciximab
U.S. FDA Resources




Primary Outcome Measures :
  1. Prevention of subacute occlusions within 30 days

Secondary Outcome Measures :
  1. Prevention of restenosis up to 3 years
  2. Prevention of target lesion revascularization
  3. Improvement of the clinical status
  4. Change of ABI
  5. Hospital days
  6. all secondary outcomes at 30 days, 6 months, one year, and 3 years (telephone contact after 3 years)


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00156611     History of Changes
Other Study ID Numbers: R-1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2006
Last Verified: September 2006

Keywords provided by University Hospital Tuebingen:
peripheral vascular disease
intervention
restenosis
Age above 18 years

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Atherosclerosis
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Abciximab
Anticoagulants
Platelet Aggregation Inhibitors