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

September 11, 2006 updated by: University Hospital Tuebingen

ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease - A Randomized Prospective Trial (RIO-Trial)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

420

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University of Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prevention of subacute occlusions within 30 days

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

University of Bern

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion

December 1, 2009

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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