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 < 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.
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 < 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: Guilherme V Silva; Marlos R Fernandes; Cristiano O Cardoso; William R Miranda; Neil Strickman; Ali Mortazavi; Eduardo A Hernandez-Vila; Arup Achari; Zvonimir Krajcer Journal: Tex Heart Inst J Date: 2011
Authors: Dmitriy N Feldman; Ehrin J Armstrong; Herbert D Aronow; Subhash Banerjee; Larry J Díaz-Sandoval; Michael R Jaff; Sasanka Jayasuriya; Safi U Khan; Andrew J Klein; Sahil A Parikh; Kenneth Rosenfield; Mehdi H Shishehbor; Rajesh V Swaminathan; Christopher J White Journal: Catheter Cardiovasc Interv Date: 2020-05-14 Impact factor: 2.692
Authors: Brian G DeRubertis; Peter L Faries; James F McKinsey; Rabih A Chaer; Matthew Pierce; John Karwowski; Alan Weinberg; Roman Nowygrod; Nicholas J Morrissey; Harry L Bush; K Craig Kent Journal: Ann Surg Date: 2007-09 Impact factor: 12.969