ArticleCardiology research2025
Safety and Performance of the MOZEC Sirolimus-Eluting Coronary Balloon in the Treatment of Stenotic Coronary Artery Lesions: A Real-World, Multicenter, Post-Marketing Surveillance Study.
Article in Cardiology research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07038408 (Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.), which is not on this map. Not yet cited in PubMed.
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Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.
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Abstract
Background: Drug-eluting balloons, surface-coated with antiproliferative agents such as sirolimus or paclitaxel, have emerged as an alternative therapeutic option for coronary stenosis. This study evaluated safety and effectiveness of the MOZEC sirolimus-eluting percutaneous transluminal coronary angioplasty (PTCA) balloon dilation catheter (Meril Life Sciences Pvt. Ltd., India) across diverse clinical scenarios in coronary artery stenosis treatment. Methods: A prospective, single-arm, multicenter, real-world, post-marketing surveillance study evaluated the safety and performance of the MOZEC sirolimus-eluting balloon (SEB) in treating native coronary artery disease in daily clinical practice. Patients were followed for 24 months, with clinical visits or telephonic calls at 1, 6, 12, and 24 months after the index procedure. Safety endpoints included major adverse cardiac events (MACEs), and performance endpoints include change in late lumen loss, clinical success, and device success. Results: A total of 141 patients were enrolled in the study. The MOZEC SEB was used in 127 (70.17%) Conclusions: The application of MOZEC SEB in various clinical scenarios demonstrated safety and efficacy over long-term follow-up. These findings align with the favorable vessel healing observed during the 6-month imaging follow-up.
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