Phase 3
Completed N=125
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Iliac Artery Stenosis
Source: ClinicalTrials.gov NCT00896337 ↗
Enrolled (actual)
125
Serious AEs
61.6%
Results posted
Jul 2012
Primary outcomePrimary: Device- and/or Procedure-related Major Adverse Events (MAE) — 3.4 percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device- and/or Procedure-related Major Adverse Events (MAE) |
3.4 | <0.0001 sig |
| SECONDARY Death |
6.5 | — |
| SECONDARY Amputation of Index Limb |
— | — |
| SECONDARY Target Vessel Revascularization (TVR) |
12.9 | — |
| SECONDARY Myocardial Infarction (MI) |
0.0 | — |
| SECONDARY Technical Success |
100 | — |
| SECONDARY Procedure Success |
99.2 | — |
| SECONDARY Early Clinical Success |
87.6 | — |
| SECONDARY Late Clinical Success |
95.3 | — |
| SECONDARY Early Hemodynamic Success |
66.2 | — |
| SECONDARY Late Hemodynamic Success |
63.6 | — |
| SECONDARY Rutherford Classification Distribution |
76.4; 12.3; 10.4; 0.9; 0; 0 | — |
| SECONDARY Acute Stent Thrombosis |
0.0 | — |
| SECONDARY Sub-acute Stent Thrombosis |
2.5 | — |
| SECONDARY Stent Thrombosis |
4.0 | — |
| SECONDARY Target Lesion Revascularization (TLR) |
10.1 | — |
| SECONDARY Ankle-Brachial Index (ABI) |
0.96 | — |
| SECONDARY Ankle-Brachial Index |
0.96 | — |
| SECONDARY Primary Patency |
93.9 | — |
| SECONDARY Primary-assisted Patency (PAP) |
96.0 | — |
| SECONDARY Secondary Patency |
98.0 | — |
| SECONDARY Restenosis Assessed by Duplex Ultrasound |
6.1 | — |
| SECONDARY Walking Impairment Questionnaire Score - Distance |
55.88 | — |
| SECONDARY Walking Impairment Questionnaire Score - Speed |
47.96 | — |
| SECONDARY Walking Impairment Questionnaire Score-Stair Climbing |
26.14 | — |
| SECONDARY Walking Impairment Questionnaire Score - Stair Climbing |
57.72 | — |
Eligibility Criteria
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 only one target lesion treated per side
- Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent)
- Length of diseased segment(s) = 50% (operator visual assessment)
- Reference vessel diameter >= 5 mm and 600,000 mm3
- Serum creatinine > 2.0 mg/dL
- Dialysis-dependent end stage renal disease
- Pregnancy
- Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial
- Known allergy to Nitinol
- Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel
- Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography
- Target lesion is within or near an aneurysm
- Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
- Perforated vessel as evidenced by extravasation of contrast media
- Vascular graft, aneurysm or postsurgical stenosis of the target vessel
- Multiple lesions in the same target vessel unable to be treated with a maximum of two stents
Data sourced from ClinicalTrials.gov (NCT00896337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.