Clinical trial NCT05402878: OUTCOME AND SAFETY OF RECANALIZATION TREATMENTS IN ISCHEMIC STROKE DUE TO ACUTE BASILAR ARTERY OCCLUSION
Official title: RECANALISATION THERAPY IN ISCHEMIC STROKE DUE TO BASILAR ARTERY OCCLUSION IN PEOPLE 115 HOSPITAL, VIETNAM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Basilar Artery Occlusion
Keywords: BASILAR ARTERY OCCLUSION
RECANALISATION THERAPY
Lead sponsor: 115 People's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were acute ischemic stroke due to basilar artery occlusion admitted People 115 Hospital and treated recanalisation therapies : intravenous tPA, bridging tPA and thrombectomy or thrombectomy alone.

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.

Eligibility criteria: 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

Primary outcomes:
measure: favourable outcome
timeFrame: 90 (± 14 days) after procedure
Secondary outcomes:
measure: good outcome
timeFrame: 90 (± 14 days) after procedure
measure: mortality
timeFrame: 90 (± 14 days) after procedure
measure: Dichotomized mRS score
timeFrame: 90 (± 14 days) after procedure
measure: Symptomatic intracerebral hemorrhage (sICH)
timeFrame: within 72 hours after procedure
measure: Any intracerebral hemorrhage
timeFrame: within 72 hours after procedure
measure: Procedural related complications
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: People 115 Hospital
state: Ho Chi Minh City
Study officials:
affiliation: People 115 Hospital
name: Huy Thang Nguyen, Professor
role: STUDY_DIRECTOR
References: