title: The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial.
abstract: OBJECTIVE
  To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions.
  
  
  METHODS
  The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months.
  
  
  RESULTS
  The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%).
  
  
  CONCLUSIONS
  The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.
authors.affiliation: 1 Cleveland Clinic Foundation, Cleveland, Ohio, USA.
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Clair
authors.forename: Julie
authors.initials: J
authors.lastname: Adams
authors.forename: Bernard
authors.initials: B
authors.lastname: Reen
authors.forename: Robert
authors.initials: R
authors.lastname: Feldman
authors.forename: Jean
authors.initials: J
authors.lastname: Starr
authors.forename: Juan
authors.initials: J
authors.lastname: Diaz-Cartelle
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D000368:Aged; D000497:Alloys; D055109:Ankle Brachial Index; D003251:Constriction, Pathologic; D004185:Disability Evaluation; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014481:United States; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol