| Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. | |
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MedLine Citation:
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PMID: 16105918 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: Despite suboptimal results, angioplasty of femoropopliteal arterial lesions has been a mainstay of endovascular therapy for many years. The recent introduction of cryoplasty marks a potential advance in the ability to effectively treat peripheral arterial atherosclerotic stenoses. This article presents the results of a prospective, multicenter trial that evaluated the efficacy of cryoplasty for femoropopliteal disease. MATERIALS AND METHODS: One hundred two patients with claudication and lesions of the superficial femoral and popliteal arteries of no greater than 10 cm were studied. All patients were treated with a primary strategy of stand-alone cryoplasty with use of the PolarCath cryoplasty system. The primary endpoints of the study were acute technical success and clinical patency at 9 months. Technical success was defined as the ability to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. Clinical patency was defined as freedom from target lesion revascularization within 9 months. Primary patency was defined by a duplex US systolic velocity ratio no greater than 2.0. RESULTS: A total of 102 patients were enrolled at 16 centers. Of those treated, 31% had diabetes and 31% were active cigarette smokers. The majority of the lesions were confined to the superficial femoral artery (84.3%) and 14.7% presented with total occlusions. The mean vessel diameter treated was 5.5 mm +/- 0.5, the mean stenosis diameter was 87% +/- 10%, and the mean lesion length was 4.7 cm +/- 2.6. The technical success rate was 85.3% with a mean residual stenosis after cryoplasty of 11.2% +/- 11.2% (P < .05 vs baseline). Clinical patency in this group was 82.2%, as only 16 patients required target lesion revascularization during the 9-month surveillance period. Primary patency determined by duplex US was 70.1%. CONCLUSIONS: Cryoplasty demonstrated a high degree of acute angiographic success and a low frequency of target lesion revascularization. The patency rate observed compares favorably to that previously documented with conventional angioplasty. |
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Authors:
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John Laird; Michael R Jaff; Giancarlo Biamino; Thomas McNamara; Dierk Scheinert; Patrick Zetterlund; Elaine Moen; James D Joye |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study |
Journal Detail:
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Title: Journal of vascular and interventional radiology : JVIR Volume: 16 ISSN: 1051-0443 ISO Abbreviation: J Vasc Interv Radiol Publication Date: 2005 Aug |
Date Detail:
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Created Date: 2005-08-17 Completed Date: 2005-12-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9203369 Medline TA: J Vasc Interv Radiol Country: United States |
Other Details:
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Languages: eng Pagination: 1067-73 Citation Subset: IM |
Affiliation:
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Washington Hospital Center, Division of Cardiology, Indianapolis, IN, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angiography Angioplasty* Arterial Occlusive Diseases / physiopathology, radiography, therapy*, ultrasonography Cryotherapy* / instrumentation Female Femoral Artery* / radiography Humans Intermittent Claudication / physiopathology, therapy Male Popliteal Artery* / radiography Treatment Outcome Ultrasonography, Doppler, Duplex Vascular Patency |
| Comments/Corrections | |
Comment In:
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J Vasc Interv Radiol. 2005 Aug;16(8):1051-4
[PMID:
16105915
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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