title: Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial.
abstract: OBJECTIVE
  To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
  
  
  METHODS
  The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7±10.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions.
  
  
  RESULTS
  A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (<30% residual stenosis) was achieved in 90.0%. There were no in-hospital major adverse events. Primary patency (defined as a peak systolic velocity ratio <2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months.
  
  
  CONCLUSIONS
  In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.
authors.affiliation: 1 University of California Davis Health System, Sacramento, California, USA.
authors.forename: John R
authors.initials: JR
authors.lastname: Laird
authors.forename: Ash
authors.initials: A
authors.lastname: Jain
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Robert
authors.initials: R
authors.lastname: Feldman
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Ehrin J
authors.initials: EJ
authors.lastname: Armstrong
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D001783:Blood Flow Velocity; D002908:Chronic Disease; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D020127:Recovery of Function; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D061205:Vascular Calcification / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol