Dr Luc Stockx, Department of Medical Imaging, Genk, Belgium, and principal investigator of the MELODIE clinical trial has announced 12-month data at this year's Paris Course on Revascularization (EuroPCR) meeting, in France.
The MELODIE trial was designed to prove the non-inferiority of the Express Vascular LD peripheral pre-mounted balloon expandable stent (Boston Scientific) in comparison to the Palmaz balloon expandable stent, in the treatment of narrowed or blocked iliac arteries.
MELODIE is a prospective, open-label, single-arm study of 150 patients (with 163 lesions) at nine European sites and one Canadian site designed to assess the Express Vascular LD stent in the treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic) of the iliac arteries.
The Express Vascular LD stent met its primary endpoint as demonstrated by a six-month mean percentage loss of lumen diameter of 16.2% with an upper confidence interval of 19.1%, which confirmed non-inferiority to the comparison stent. The Express Vascular LD stent also demonstrated an excellent safety profile with no device- or procedure-related deaths and no episodes of distal embolization. More than 89% of the patients were available for the study's one-year evaluation.
Stockx commented, "The Express Vascular LD stent demonstrated excellent results at one year with a high clinical success rate. In meeting its endpoint, the Express Vascular LD stent was equal to the Palmaz stent in mean percent of luminal diameter, which is a critical measure of sustained patency. This was further supported by persistent improvements in ankle brachial index and Fontaine classification."
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