NCT00156611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 12, 2006

Status Verified

September 1, 2006

First QC Date

September 7, 2005

Last Update Submit

September 11, 2006

Conditions

Arterial Occlusive Diseases

Keywords

peripheral vascular diseaseinterventionrestenosisAge above 18 years

Outcome Measures

Primary Outcomes (1)

  • Prevention of subacute occlusions within 30 days

Secondary Outcomes (6)

  • Prevention of restenosis up to 3 years

  • Prevention of target lesion revascularization

  • Improvement of the clinical status

  • Change of ABI

  • Hospital days

  • +1 more secondary outcomes

Interventions

Balloon AngioplastyPROCEDURE
ReoProDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Arterial Occlusive DiseasesPeripheral Vascular Diseases

Interventions

Angioplasty, BalloonAbciximab

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative TechniquesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Gunnar Tepe, MD

    University Hospital of Tuebingen

    PRINCIPAL INVESTIGATOR

  • Iris Baumgartner, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

January 1, 2002

Study Completion

December 1, 2009

Last Updated

September 12, 2006

Record last verified: 2006-09

Locations

DE(1)