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- Siddiqui, AH, et al.
(author)
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Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods
- 2022
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In: Journal of neurointerventional surgery. - : BMJ. - 1759-8486 .- 1759-8478. ; 14:8, s. 783-787
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Journal article (peer-reviewed)abstract
- Relationships between occlusive clot histopathology, baseline characteristics, imaging findings, revascularization rates, and clinical outcomes of stroke patients with large vessel occlusion (LVO) are not well understood. This study will assess the real-world experience on the efficacy and safety of using the EmboTrap device as the first approach in LVO patients and explore the associations between clot histological characteristics, imaging and clinical findings, revascularization rates, and clinical outcomes.MethodsProspective, global, multicenter, single-arm, imaging core laboratory, and clot analysis central laboratory observational registry. Adult patients (>18 years) with LVO, treated with EmboTrap as the first attempted device, will be eligible for study participation.ResultsUp to 1000 subjects at 50 international sites may be enrolled. Occlusive clots will be collected from at least 500 subjects. Independent central and imaging core laboratories will perform clot analysis and image adjudication. Statistical analysis will assess the association between imaging and clinical findings, clot characteristics, subject comorbidities, revascularization, and clinical outcomes. Study endpoints are functional independence (modified Rankin Scale score ≤2 at 90 days), expanded Thrombolysis In Cerebral Infarction (eTICI) score ≥2b50 rate, first-pass effect, number of passes, embolization into new territory, symptomatic intracranial hemorrhage, and 90-day mortality.ConclusionsThe EXCELLENT registry will provide reproducible effectiveness and safety data of EmboTrap for its use for mechanical thrombectomy. Additionally, the study will characterize the blood clots retrieved during mechanical thrombectomy with respect to their composition and histopathological analysis and potential correlations with clinical and imaging findings.Trial registration numberNCT03685578.
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| 2. |
- Siddiqui, AH, et al.
(author)
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Predictors of unfavorable outcomes despite substantial reperfusion: Insights from Analysis of Revascularization in Ischemic Stroke With EmboTrap II Study
- 2022
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In: Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences. - : SAGE Publications. - 2385-2011. ; 28:5, s. 556-561
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Journal article (peer-reviewed)abstract
- A considerable proportion of stroke patients have unfavorable outcomes despite substantial reperfusion during mechanical thrombectomy for large vessel occlusion. This study aimed to determine predictors of unfavorable outcomes despite substantial reperfusion (modified thrombolysis in cerebral infarction score of ≥2b). Methods We conducted a post hoc analysis of Analysis of Revascularization in Ischemic Stroke With EmboTrap, a prospective, multicenter study on the efficacy of the EmboTrap revascularization device. We included patients with anterior large vessel occlusion, substantial reperfusion within three passes, and 3-month follow-up. Univariate and multivariate logistic regression analyses were performed to determine independent predictors of dependency or death (modified Rankin Score 3–6) at 90 days. Results Of the 176 patients included in the study, 124 (70.45%) achieved modified Rankin Score of 0–2 at 90 days and 52 (29.6%) had modified Rankin Score of 3–6. On univariate analysis, patient age and initial National Institutes of Health Stroke Scale score were significantly higher in the modified Rankin Score of 3–6 groups (71.4 ± 11.3 years vs. 66.0 ± 13.1 years, 0.01; 18.9 ± 4.13 vs. 14.6 ± 4.36, p < 0.01, respectively). Mean number of passes and symptomatic intracranial hemorrhage were also higher in patients with modified Rankin Score of 3–6 (2.46 ± 1.42 vs. 1.65 ± 0.9, p < 0.01; 13.5% vs. 2.4%, p = 0.008). On multivariate analysis, initial National Institutes of Health Stroke Scale score and mean number of passes and were independent predictors of modified Rankin Score of 3–6 at 90 days. Conclusion More severe initial neurologic deficit and higher number of passes in patients with substantial reperfusion were independent predictors of dependency or death. These findings highlight a reduction in the number of passes required to achieve reperfusion as a therapeutic target to improve the outcome after thrombectomy.
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