title: Stent placement in the superficial femoral and proximal popliteal arteries with the innova self-expanding bare metal stent system.
abstract: OBJECTIVE
  The SuperNOVA trial was designed to evaluate performance of the Innova Vascular Self-Expanding Stent System (Boston Scientific, Marlborough, MA) for treating lesions in the femoropopliteal arteries.
  
  
  METHODS
  Patients with chronic lower limb peripheral artery disease (Rutherford category 2, 3, or 4) and atherosclerotic lesions in the native superficial femoral and/or proximal popliteal artery (lengths 30-190 mm) were enrolled in this single-arm, multinational study. Major adverse events (MAEs) were defined as all-cause death through 1 month, target limb major amputation, and target lesion revascularization (TLR). Vessel primary patency was defined as core laboratory-adjudicated duplex ultrasonography-derived peak systolic velocity ratio ≤2.4 in the absence of TLR, surgical bypass of the target lesion, or major amputation of the target limb. Primary safety and efficacy endpoints were evaluated at 12 months, with follow-up through 24 months also reported.
  
  
  RESULTS
  SuperNOVA patients (N = 299; mean age 67.4 ± 9.7 years, 74% men, 41% with diabetes) had a mean lesion length of 93.2 mm. The MAE-free rate was 99.7% at 30 days, 85.8% at 12 months, and 77% at 24 months. Kaplan-Meier estimates of primary patency and TLR-free rates were 68.7% and 78.0%, respectively, at 24 months. Clinical improvements were sustained through 2 years, with 80% of patients displaying no or minimal symptoms (Rutherford category 0-1) at 24 months.
  
  
  CONCLUSIONS
  In the SuperNOVA study, the Innova Stent System demonstrated an excellent safety profile and acceptable clinical outcomes despite the challenging anatomical characteristics of the lesions. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Powell
authors.affiliation: VasCore, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: Ziekenhuis Oost-Limburg, Genk, Belgium.
authors.forename: Herman
authors.initials: H
authors.lastname: Schroë
authors.affiliation: Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Benko
authors.affiliation: Boston Scientific Corporation, Marlborough, Massachusetts.
authors.forename: Juan
authors.initials: J
authors.lastname: Diaz-Cartelle
authors.affiliation: Ev. Luth. Diakonissenanstalt Flensburg, Flensburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Müller-Hülsbeck
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D018572:Disease-Free Survival; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009656:North America; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D000069322:Self Expandable Metallic Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol
keywords: endovascular procedures; peripheral arterial disease; prospective studies; vascular patency