Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods

Abstract

BackgroundRelationships 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.

MASTRO I: Meta-Analysis and Systematic Review of thrombectomy stent retriever outcomes: comparing functional, safety and recanalization outcomes between EmboTrap, Solitaire and Trevo in acute ischemic stroke

“…EmboTrap was designed to improve clot engagement in thrombectomy across a range of clots with varying composition [ 74 ]. While EmboTrap outperformed other SRs in the current study, to date, no head-to-head RCTs comparing SRs for use in MT for AIS have been published.…”

Quality assessment of histopathological stainings on prolonged formalin fixed thrombus tissues retrieved by mechanical thrombectomy

“…This study was part of a prospective, multicenter, and international Embotrap Extraction and Clot Evaluation and Lesion Evaluation for Neuro Thrombectomy (EXCELLENT) registry ( 11 ). The study protocol was approved by the institutional review board at each institution ( Supplementary Table S1 ), and written informed consent was obtained from enrolled patients ( 11 ). Patients were included in the study if they were ≥ 18 years, had undergone thrombectomy for ELVO, and had embolic material available for analysis.…”