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NCT00896337 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 3
Development phase
125
Enrollment target

NCT00896337: Completed Phase 3 study, sponsored by Boston Scientific Corporation.

NCT00896337 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00896337, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 3
Development phase
125 participants
Enrollment target

Study 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.

Primary Outcome

MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months

Interventions

  • DEVICE Epic™ Nitinol Stent System
  • DRUG Anti-platelet therapy
  • DRUG Anti-coagulation therapy

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2009-05
Est. Completion 2013-12
Phase Phase 3
Boston Scientific Corporation

280 total trials

What the finished NCT00896337 record still lists

NCT00896337 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 3 interventions - of which Epic™ Nitinol Stent System is the first listed.

NCT00896337 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00896337 about?

NCT00896337 is a clinical study titled "EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries". 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.

What is the current status of trial NCT00896337?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2009-05. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00896337?

The interventions under investigation include: Epic™ Nitinol Stent System (DEVICE), Anti-platelet therapy (DRUG), Anti-coagulation therapy (DRUG).

Who is sponsoring clinical trial NCT00896337?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00896337's enrollment target sits among peer trials

125 1605th of 2000 higher than 391 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00896337, the US trial registry maintained by the National Library of Medicine. NCT00896337 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.