Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00896337 | EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries | PHASE3 | COMPLETED | 125 | — | — | May 1, 2009 | Dec 1, 2013 | May 7, 2015 | 28 | United States |
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
| Arm | Type | Description |
|---|---|---|
| ORION | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Epic™ Nitinol Stent System | DEVICE | The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system. |
| Anti-platelet therapy | DRUG | 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 therapy | DRUG | Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice. |
Inclusion Criteria: * Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4) * Lifestyle-limiting claudication or rest pain * De novo or restenotic lesions in the common and/or external iliac artery * Subjects with bilateral disease may have o...