Literature DB >> 22149221

A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry.

Dierk Scheinert1, Lars Grummt, Michael Piorkowski, Jacqueline Sax, Susanne Scheinert, Matthias Ulrich, Martin Werner, Yvonne Bausback, Sven Braunlich, Andrej Schmidt.   

Abstract

PURPOSE: To examine the efficacy and integrity of a novel interwoven self-expanding nitinol stent system for the treatment of complex femoropopliteal lesions in a "real world" medical practice.
METHODS: This retrospective analysis included 107 consecutive patients (77 men; mean age 68.9 years) with atherosclerotic femoropopliteal lesions (occlusions in 31%) who underwent implantation of 137 SUPERA stents. The patients were followed for up to 24 months by Doppler ultrasound examinations, radiography of the stent, and assessments of Rutherford-Becker class and ankle-brachial index (ABI).
RESULTS: The mean implanted stent length was 111±50 mm (range 40-270). Procedure success (residual stenosis <30%) was achieved in 99% of procedures. The 6-, 12-, and 24-month cumulative primary patency rates (± standard error) were 93.1%±2.5%, 84.7%±3.6%, and 76.1%±4.5%, respectively, and the secondary patency rates were 99.0%±0.1%, 94.8%±0.2% and 91.9%±0.3%, respectively. Between baseline and 24 months, mean ABI increased from 0.68±0.14 to 0.87±0.10 and the mean Rutherford-Becker class decreased from 3.3±0.7 to 2.0±1.0 (p<0.0001 for both). Radiographs performed in 91 patients at a mean of 16.8±7.0 months found no stent fractures.
CONCLUSION: Over a 2-year surveillance period, excellent durability without stent fractures was documented after implantation of the SUPERA stent in complex femoropopliteal lesions. In addition, significant improvements were observed in symptom classification and hemodynamics.

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Year:  2011        PMID: 22149221     DOI: 10.1583/11-3500.1

Source DB:  PubMed          Journal:  J Endovasc Ther        ISSN: 1526-6028            Impact factor:   3.487


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