title: Cryoplasty for the treatment of femoropopliteal arterial disease: extended follow-up results.
abstract: OBJECTIVE
  To report the findings from a multicenter study of patients treated with cryoplasty who were then followed for an average of > 2 years post-treatment.
  
  
  METHODS
  Extended clinical follow-up was obtained for 70 patients (45 men; mean age 70.5 +/- 8.8 years) who originally received cryoplasty therapy to treat symptoms of intermittent claudication as part of a multicenter investigational device exemption (IDE) study. For all subjects, cryoplasty was used to treat stenoses or occlusions < or = 10 cm in the femoropopliteal arteries. The original IDE study protocol enrolled 102 patients with a primary endpoint of target lesion patency at 9 months post-treatment. This collection of additional longer term follow-up data was initiated 2.5 years after the onset of study enrollment.
  
  
  RESULTS
  Extended clinical follow-up ranged from 11 to 41 months (mean 31). The clinical patency rate (freedom from target lesion revascularization) calculated by the Kaplan-Meier method was 83.2% after the original follow-up period of 300 days. After > 3 years (1253 days), the clinical patency rate was well maintained at 75.0%.
  
  
  CONCLUSIONS
  Long-term data indicate that cryoplasty is a durable therapy, with relatively low long-term restenosis rates compared to other endovascular treatment approaches.
authors.affiliation: Cardiovascular Research Institute, Washington Hospital Center, Washington, DC 20010, USA. John.R.Laird@medstar.net
authors.forename: John R
authors.initials: JR
authors.lastname: Laird
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Biamino
authors.forename: Thomas
authors.initials: T
authors.lastname: McNamara
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Patrick
authors.initials: P
authors.lastname: Zetterlund
authors.forename: Elaine
authors.initials: E
authors.lastname: Moen
authors.forename: James D
authors.initials: JD
authors.lastname: Joye
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D002986:Clinical Trials as Topic; D017679:Cryotherapy / Q000295:instrumentation / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011859:Radiography