Basilar Artery Occlusion Clinical Trial
Official title:
RECANALISATION THERAPY IN ISCHEMIC STROKE DUE TO BASILAR ARTERY OCCLUSION IN PEOPLE 115 HOSPITAL, VIETNAM
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 CTA/MRA/DSA 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 CTA/MRA/DSA. Main study parameters/outcomes: 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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Symptoms and signs compatible with ischemia in the basilar artery territory. - Basilar artery occlusion (BAO) confirmed by CTA or MRA or DSA. - Age 18 years or older - Patients were treated with one of these among therapies IVT alone, bridging IVT and thrombectomy or thrombectomy alone.. Exclusion Criteria: - Patients did not agree to enroll. Imaging exclusion criteria: - High-density lesion consistent with hemorrhage of any degree - Significant cerebellar mass effect or acute hydrocephalus |
Country | Name | City | State |
---|---|---|---|
Vietnam | People 115 Hospital | Ho Chi Minh | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
115 People's Hospital |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | favourable outcome | a modified Rankin Score of 0-3 | 90 (± 14 days) after procedure | |
Secondary | good outcome | a modified Rankin Score of 0-2 | 90 (± 14 days) after procedure | |
Secondary | mortality | Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%. | 90 (± 14 days) after procedure | |
Secondary | Dichotomized mRS score | mRS (0-2 versus 3-6 and 0-4 versus 5-6 ) | 90 (± 14 days) after procedure | |
Secondary | Symptomatic intracerebral hemorrhage (sICH) | SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by =4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death. | within 72 hours after procedure | |
Secondary | Any intracerebral hemorrhage | intracerebral hemorrhage was defined according ECASS definition. | within 72 hours after procedure | |
Secondary | Procedural related complications | arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on | Perioperative period |
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