Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial
Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods...
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Published in | Journal of endovascular therapy Vol. 21; no. 6; pp. 765 - 774 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Los Angeles, CA
SAGE Publications
01.12.2014
Allen Press Inc |
Subjects | |
Online Access | Get full text |
ISSN | 1526-6028 1545-1550 1545-1550 |
DOI | 10.1583/14-4790R.1 |
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Summary: | Purpose:
To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery.
Methods:
The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7±8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5±5.31 cm, range 20–40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within ±10% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year.
Results:
The median follow-up was 12.3 months (mean 12.3±0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement.
Conclusion:
This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. One-year primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes. |
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Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 14 content type line 23 |
ISSN: | 1526-6028 1545-1550 1545-1550 |
DOI: | 10.1583/14-4790R.1 |