CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 enrolled
Drug / intervention
Anti-platelet therapy +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00896337
NCT00896337Phase 3Completed
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A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

Boston Scientific Corporation·interventional·Posted May 11, 2009·Updated May 7, 2015

In Brief

A Phase 3 clinical trial evaluating Epic™ Nitinol Stent System, Anti-platelet therapy, and 1 other intervention for Iliac Artery Stenosis. Completed, enrolled 125 participants across 28 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIliac Artery Stenosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2011
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.1 years ago

Interventions

Epic™ Nitinol Stent Systemdevice

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

Anti-platelet therapydrug

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.

Anti-coagulation therapydrug

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