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EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

NCT00896337 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2015-05-07

Study results available
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Summary

The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

Conditions

  • Iliac Artery Stenosis

Interventions

DEVICE

Epic™ Nitinol Stent System

The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.

DRUG

Anti-platelet therapy

Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.

DRUG

Anti-coagulation therapy

Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Pamela G. Grady, Ph.D. · Boston Scientific Corporation

  • Daniel G Clair, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-09-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00896337 on ClinicalTrials.gov