Conditions: Iliac Artery Stenosis
Keywords: iliac artery stenosis claudication atherosclerotic iliac disease peripheral vascular disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 125
Healthy volunteers: no

Brief 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.

Arms:
arm 1: All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.

Interventions: intervention 1: Epic™ Nitinol Stent System intervention 2: Anti-platelet therapy intervention 3: Anti-coagulation therapy
Intervention descriptions: intervention 1: The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system. intervention 2: 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. intervention 3: Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

Protocol document: