OUTCOME AND SAFETY OF RECANALIZATION TREATMENTS IN ISCHEMIC STROKE DUE TO ACUTE BASILAR ARTERY OCCLUSION

• Conditions: Basilar Artery Occlusion

• Registration Number: NCT05402878
• Lead Sponsor: 115 People's Hospital

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 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.

Detailed Description

Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known in Vietnam.Various 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 Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
favourable outcome	90 (± 14 days) after procedure	a modified Rankin Score of 0-3

Secondary Outcome Measures

Name	Time	Method
Any intracerebral hemorrhage	within 72 hours after procedure	intracerebral hemorrhage was defined according ECASS definition.
Symptomatic intracerebral hemorrhage (sICH)	within 72 hours after procedure	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.
Dichotomized mRS score	90 (± 14 days) after procedure	mRS (0-2 versus 3-6 and 0-4 versus 5-6 )
Procedural related complications	Perioperative period	arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on
good outcome	90 (± 14 days) after procedure	a modified Rankin Score of 0-2
mortality	90 (± 14 days) after procedure	Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%.

Trial Locations

Locations (1)

People 115 Hospital; 🇻🇳 Ho Chi Minh, Ho Chi Minh City, Vietnam