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Endovascular Recanalization and Standard Medical Management for Symptomatic Non-acute Intracranial Artery Occlusion: Study Protocol for a Non-randomized, 24-Month, Multicenter Study

ABSTRACT: Background: The management of patients with symptomatic non-acute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. A number of small-sample clinical studies have also discussed endovascular recanalization (ER) for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The purpose of our present study was to evaluate the technical feasibility and safety of ER for sNA-ICAO. Methods: Our group is currently undertaking a multisite, non-randomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between January 1, 2020 and December 31, 2022. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is any stroke from enrollment to 2 years of follow-up. The secondary outcomes are all-cause mortality, mRS score, NIHSS score and cognitive function from enrollment to 30 days, 3 months, 8 months, 12 months, 18 months, and 2 years of follow-up. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. Discussion: The management of patients with sNA-ICAO has been clinically challenging. The current protocol aims to evaluate the technical feasibility and safety of ER for sNA-ICAO. Trial Registration Number:www.ClinicalTrials.gov, identifier: NCT04864691.

SUBMITTER: Zhang H

PROVIDER: S-EPMC8506001 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSymptomatic intracranial hemorrhage (sICH) is a serious complication after endovascular treatment for ischemic stroke. We aimed to identify determinants of its occurrence and location.MethodsWe retrospectively analyzed data from the Dutch MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) and MR CLEAN registry. We included adult patients with a large vessel occlusion in the anterior circulation who underwent endovascular treatment within 6.5 hours of stroke onset. We used univariable and multivariable logistic regression analyses to identify determinants of overall sICH occurrence, sICH within infarcted brain tissue, and sICH outside infarcted brain tissue.ResultsSICH occurred in 203 (6%) of 3313 included patients and was located within infarcted brain tissue in 50 (25%), outside infarcted brain tissue in 23 (11%), and both within and outside infarcted brain tissue in 116 (57%) patients. In 14 patients (7%), data on location were missing. Prior antiplatelet use, baseline systolic blood pressure, baseline plasma glucose levels, post-endovascular treatment modified treatment in cerebral ischemia score, and duration of procedure were associated with all outcome parameters. In addition, determinants of sICH within infarcted brain tissue included history of myocardial infarction (adjusted odds ratio, 1.65 [95% CI, 1.06-2.56]) and poor collateral score (adjusted odds ratio, 1.42 [95% CI, 1.02-1.95]), whereas determinants of sICH outside infarcted brain tissue included level of occlusion on computed tomography angiography (internal carotid artery or internal carotid artery terminus compared with M1: adjusted odds ratio, 1.79 [95% CI, 1.16-2.78]).ConclusionsSeveral factors, some potentially modifiable, are associated with sICH occurrence. Further studies should investigate whether modification of baseline systolic blood pressure or plasma glucose level could reduce the risk of sICH. In addition, determinants differ per location of sICH, supporting the hypothesis of varying underlying mechanisms.RegistrationURL: https://www.isrctn.com/; Unique identifier: ISRCTN10888758.

Project description:BACKGROUND AND PURPOSE:The Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) prospective study aims to determine factors predicting recurrence after endovascular treatment for intracranial aneurysms. In this publication, we review endovascular techniques and present the study population. Characteristics of treated and untreated unruptured aneurysms were analyzed. MATERIALS AND METHODS:Sixteen neurointerventional departments prospectively enrolled patients treated for ruptured and unruptured intracranial aneurysms between December 2013 and May 2015. Patient demographics, aneurysm characteristics, and endovascular techniques were recorded. RESULTS:A total of 1289 patients with 1761 intracranial aneurysms, 835 (47.4%) ruptured, were enrolled. Of these, 1359 intracranial aneurysms were treated by endovascular means. Ruptured intracranial aneurysms were treated by coiling and balloon-assisted coiling in 97.8% of cases. In unruptured intracranial aneurysms, the rates of flow diversion, flow disruption, and stent-assisted coiling were 11.6%, 6.9%, and 7.8%, respectively. Rupture status and aneurysm location, neck diameter, and sac size significantly influenced the chosen technique. Treated unruptured intracranial aneurysms, compared with untreated counterparts, had larger aneurysm sacs (7.6 ± 4.0 versus 3.4 ± 2.0 mm; P < 0.001) and neck dimensions (4.1 ± 2.2 versus 2.4 ± 1.3 mm; P < 0.001) and more frequently an irregular form (84.6% versus 44.4%; P < 0.001). Also, its location influenced whether an unruptured intracranial aneurysm was treated. CONCLUSIONS:Our study provides an overview of current neurointerventional practice in the ARETA cohort. The technique choice was influenced by aneurysm morphology, location, and rupture status. Flow diversion, flow disruption, and stent-assisted coiling were commonly used in unruptured intracranial aneurysms, while most ruptured intracranial aneurysms were treated with coiling and balloon-assisted coiling.

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Endovascular Recanalization and Standard Medical Management for Symptomatic Non-acute Intracranial Artery Occlusion: Study Protocol for a Non-randomized, 24-Month, Multicenter Study

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