Abstract
PURPOSE: To evaluate the effectiveness, safety, and short-term patency rates of a self-expandable nitinol stent (JostentSelfX; Abbott Laboratories, Chicago, IL) for treatment of iliac artery stenoses. MATERIALS AND METHODS: In a prospective study, 34 chronic iliac artery stenoses were primarily treated in 27 patients (mean age, 61.7 years +/- 9.4) by placement of a JostentSelfX Handling and ...
Abstract
PURPOSE: To evaluate the effectiveness, safety, and short-term patency rates of a self-expandable nitinol stent (JostentSelfX; Abbott Laboratories, Chicago, IL) for treatment of iliac artery stenoses. MATERIALS AND METHODS: In a prospective study, 34 chronic iliac artery stenoses were primarily treated in 27 patients (mean age, 61.7 years +/- 9.4) by placement of a JostentSelfX Handling and visibility of the stent was scored on a 4-point scale. Before stent placement, within 3 days after stent placement and at 6 months follow-up, the clinical history, clinical stage according to the Rutherford classification, and the ankle-brachial index (ABI) were assessed. Intra-arterial digital subtraction angiography including measurement of the mean pressure gradient was performed at the time of stent placement and at 6 months follow-up or in case of recurrence of symptoms. The Wilcoxon signed rank test and Kaplan-Meier method were applied for statistical analysis. RESULTS: The immediate technical success rate was 94%. The clinical success rate immediately after the procedure was 96% and 85% at 6 months follow-up. Stent placement significantly decreased the severity of stenoses as well as the mean pressure gradients and significantly increased the ABI. Handling of the stent was judged good. No misplacement occurred. Foreshortening during deployment was negligible and no stent migration was seen. However, visibility of the stent during fluoroscopy was ranked as moderate to bad. Follow-up at 6 months revealed the cumulative angiographic primary patency rate (< 50% restenosis and < 10 mm Hg mean pressure gradient) to be 0.96. CONCLUSION: The evaluated self-expandable nitinol stent is an effective tool in treating iliac artery stenoses. Apart from poor visibility, handling was good. The angiographic patency rate is comparable with data reported in other stent trials.
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