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
Bibliographic record
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: lesions, 40 (22.1%) in-stent restenosis lesions, and 14 (7.73%) bifurcations lesions. Over the 24-month follow-up period (n = 134), six cumulative MACEs (4.47%) were observed, comprising two cardiac deaths (1.49%), five myocardial infarctions (3.73%), and four target lesion revascularizations (2.99%). Late lumen loss analysis included 17 patients who underwent additional coronarography at the 6-month follow-up. In-segment and in-device late lumen loss at 6-month follow-up was 0.14 ± 0.37 mm. 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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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".