Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05402878
Status:
UNKNOWN
Last Update Posted:
2022-07-26
First Post:
2022-05-26
Brief Title:
OUTCOME AND SAFETY OF RECANALIZATION TREATMENTS IN ISCHEMIC STROKE DUE TO ACUTE BASILAR ARTERY OCCLUSION
Sponsor:
115 Peoples Hospital
Organization:
115 Peoples Hospital
Study Overview
Official Title:
RECANALISATION THERAPY IN ISCHEMIC STROKE DUE TO BASILAR ARTERY OCCLUSION IN PEOPLE 115 HOSPITAL VIETNAM
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale Recently two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy EVT in patients with an acute symptomatic basilar artery occlusion BAO However the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results
Objective To assess the outcomes and prognostic factors of recanalization therapy in patients with BAO caused by a CTAMRADSA confirmed occlusion of the basilar artery
Study design This is a prospective observational study Study population Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTAMRADSA
Main study parametersoutcomes Favorable outcome at day 90 defined as a modified Rankin Score mRS - functional scale of 0-3 The estimate will be adjusted for the known prognostic variables age time from onset to treatment stroke severity NIHSS PC ASPECT and collateral flow and adjusted and unadjusted estimates with corresponding 95 confidence intervals will be reported
Objective To assess the outcomes and prognostic factors of recanalization therapy in patients with BAO caused by a CTAMRADSA confirmed occlusion of the basilar artery
Study design This is a prospective observational study Study population Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTAMRADSA
Main study parametersoutcomes Favorable outcome at day 90 defined as a modified Rankin Score mRS - functional scale of 0-3 The estimate will be adjusted for the known prognostic variables age time from onset to treatment stroke severity NIHSS PC ASPECT and collateral flow and adjusted and unadjusted estimates with corresponding 95 confidence intervals will be reported
Detailed Description:
Acute basilar artery thrombosis is associated with a poor prognosis Prevalence of basilar artery occlusion are not known in VietnamVarious treatments were tried in groups of patients with acute ischemic stroke due to basilar artery occlusion but evidence based was not cleared previous studies Therefore we conduct this study to evaluate the efficacy and safety of recanalization therapies which included intravenous thrombosis alone endovascular alone or bridging IVT and endovascular in basilar artery occlusion stroke patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None