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

NCT ID: NCT05402878

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Basilar Artery Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.


* High-density lesion consistent with hemorrhage of any degree
* Significant cerebellar mass effect or acute hydrocephalus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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115 People's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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NGUYEN THI BICH HUONG

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huy Thang Nguyen, Professor

Role: STUDY_DIRECTOR

People 115 Hospital

Locations

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People 115 Hospital

Ho Chi Minh City, Ho Chi Minh City, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Bich Huong Nguyen

Role: CONTACT

+84989689525

Huy Thang Nguyen

Role: CONTACT

Facility Contacts

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Bich Huong Nguyen

Role: primary

+84989689525

Other Identifiers

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People 115 Hospital

Identifier Type: -

Identifier Source: org_study_id

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