NCT00896337

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

A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.

Conditions

• Iliac Artery Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-09-01
• Completion: 2013-12-01
• First posted: 2009-05-11
• Last updated: 2015-05-07
• Results posted: 2012-07-03

Locations

28 sites across 1 country: United States