Cryoplasty for the treatment of femoropopliteal arterial disease: Extended follow-up results

John R. Laird, Giancarlo Biamino, Thomas McNamara, Dierk Scheinert, Patrick Zetterlund, Elaine Moen, James D. Joye

Research output: Contribution to journalArticlepeer-review

60 Scopus citations


Purpose: 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 ≤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.

Original languageEnglish (US)
JournalJournal of Endovascular Therapy
Issue numberSUPPL. 2
StatePublished - Feb 2006
Externally publishedYes


  • Angioplasty
  • Cryoplasty
  • Endovascular therapy
  • Femoropopliteal segment
  • Intermittent claudication
  • Peripheral arterial disease
  • Restenosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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