A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry
| Autor: | Bernardo Cortese, Prakash Sojitra, Dinesh Shah, Keyur Parikh, Ranjan Shetty, Gaetano Di Palma, Sameer Dani |
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| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Psychological intervention Myocardial Infarction Infarction India Coronary Artery Disease 030204 cardiovascular system & hematology Balloon Cardiac Catheters 03 medical and health sciences 0302 clinical medicine Restenosis Coated Materials Biocompatible Risk Factors medicine Humans In patient 030212 general & internal medicine Myocardial infarction Prospective Studies Registries Angioplasty Balloon Coronary Aged Sirolimus business.industry Cardiovascular Agents General Medicine Equipment Design Middle Aged medicine.disease Surgery Treatment Outcome Coronary vessel Retreatment Feasibility Studies Female Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Cardiovascular revascularization medicine : including molecular interventions. 20(3) |
| ISSN: | 1878-0938 |
| Popis: | Background The aim of the Nanolute registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions. Methods All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction. Results A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1). Conclusion The Nanolute prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions. |
| Databáze: | OpenAIRE |
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