title: Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.
abstract: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions.
  
  
  
  Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed.
  
  
  
  Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender.
  
  
  
  Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.
authors.affiliation: 1 Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Rundback
authors.affiliation: 2 Imelda Hospital, Bonheiden, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.affiliation: 3 Cardiovascular Medicine, Temple University Hospital, Philadelphia, PA, USA.
authors.forename: Jon C
authors.initials: JC
authors.lastname: George
authors.affiliation: 4 Vascular Center and Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: 5 Division of Vascular Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: Peter L
authors.initials: PL
authors.lastname: Faries
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation; D055109:Ankle Brachial Index; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D005060:Europe; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency
keywords: balloon-expandable stent; claudication; common iliac artery; external iliac artery; iliac artery; peripheral artery disease; stent