First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study
RationaleThe clinical impact of a novel mechanical thrombectomy strategy, which integrates distal access with flow reversal and flow arrest via a distal balloon, all within a single procedure [Safety and Efficacy of the overall throMbectomy system for sTroke (SEMTiC) strategy], has not been tested.A...
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Frontiers Media S.A.
2025-03-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2025.1537008/full |
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| author | Luís San Román Laura Ludovica Gramegna Sara Pich Laura Domingo-Rodriguez Marta Duran Lluís Duocastella Juan Macho |
| author_facet | Luís San Román Laura Ludovica Gramegna Sara Pich Laura Domingo-Rodriguez Marta Duran Lluís Duocastella Juan Macho |
| author_sort | Luís San Román |
| collection | DOAJ |
| description | RationaleThe clinical impact of a novel mechanical thrombectomy strategy, which integrates distal access with flow reversal and flow arrest via a distal balloon, all within a single procedure [Safety and Efficacy of the overall throMbectomy system for sTroke (SEMTiC) strategy], has not been tested.AimThe SEMTiC-01 study is the first prospective, multicenter in vivo study evaluating the safety and efficacy of the combined thrombectomy system—iNedit, iNdeep, and iNtercept—in patients with acute ischemic stroke.Sample size estimatesThe study was designed with a sequential structure based on the efficacy endpoint (eTICI ≥2b) reported in the literature [71.1% with a 95% confidence interval of (68.5%, 73.8%)]. An interim analysis was set for 115 patients and a final analysis for 225 patients, ensuring 98% power at a one-sided 0.025 significance level, with a 2.6% non-inferiority margin and a 15% assumed withdrawal rate.DesignSEMTiC-01 is a prospective, multicenter, single-arm, open-label clinical safety and efficacy investigation.OutcomePrimary efficacy endpoint: expanded treatment in cerebral infarction score (eTICI) ≥2b revascularization within ≤ 3 stent retriever passes. Primary safety endpoint: monitoring serious adverse events within 24 h post-intervention and all-cause mortality at 90 days. |
| format | Article |
| id | doaj-art-099d88fbb2564c089ac997276209a879 |
| institution | OA Journals |
| issn | 1664-2295 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj-art-099d88fbb2564c089ac997276209a8792025-08-20T01:57:21ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-03-011610.3389/fneur.2025.15370081537008First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the studyLuís San Román0Laura Ludovica Gramegna1Sara Pich2Laura Domingo-Rodriguez3Marta Duran4Lluís Duocastella5Juan Macho6Department of Neuroradiology, Hospital Clinic, Barcelona, SpainVall d'Hebron Institut de Recerca, Vall d'Hebron Barcelona Hospital Campus, Barcelona, SpainiVascular, Barcelona, SpainiVascular, Barcelona, SpainiVascular, Barcelona, SpainiVascular, Barcelona, SpainDepartment of Neuroradiology, Hospital Clinic, Barcelona, SpainRationaleThe clinical impact of a novel mechanical thrombectomy strategy, which integrates distal access with flow reversal and flow arrest via a distal balloon, all within a single procedure [Safety and Efficacy of the overall throMbectomy system for sTroke (SEMTiC) strategy], has not been tested.AimThe SEMTiC-01 study is the first prospective, multicenter in vivo study evaluating the safety and efficacy of the combined thrombectomy system—iNedit, iNdeep, and iNtercept—in patients with acute ischemic stroke.Sample size estimatesThe study was designed with a sequential structure based on the efficacy endpoint (eTICI ≥2b) reported in the literature [71.1% with a 95% confidence interval of (68.5%, 73.8%)]. An interim analysis was set for 115 patients and a final analysis for 225 patients, ensuring 98% power at a one-sided 0.025 significance level, with a 2.6% non-inferiority margin and a 15% assumed withdrawal rate.DesignSEMTiC-01 is a prospective, multicenter, single-arm, open-label clinical safety and efficacy investigation.OutcomePrimary efficacy endpoint: expanded treatment in cerebral infarction score (eTICI) ≥2b revascularization within ≤ 3 stent retriever passes. Primary safety endpoint: monitoring serious adverse events within 24 h post-intervention and all-cause mortality at 90 days.https://www.frontiersin.org/articles/10.3389/fneur.2025.1537008/fullmechanical thrombectomyacute ischemic strokeballoon guide catheterdistal aspiration catheterendovascular stroke treatment |
| spellingShingle | Luís San Román Laura Ludovica Gramegna Sara Pich Laura Domingo-Rodriguez Marta Duran Lluís Duocastella Juan Macho First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study Frontiers in Neurology mechanical thrombectomy acute ischemic stroke balloon guide catheter distal aspiration catheter endovascular stroke treatment |
| title | First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study |
| title_full | First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study |
| title_fullStr | First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study |
| title_full_unstemmed | First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study |
| title_short | First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study |
| title_sort | first prospective single arm multicenter study to evaluate safety and efficacy of the overall thrombectomy system inedit indeep and intercept for acute ischemic stroke rationale beyond the study |
| topic | mechanical thrombectomy acute ischemic stroke balloon guide catheter distal aspiration catheter endovascular stroke treatment |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2025.1537008/full |
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