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

Basilar Artery Occlusion Clinical Trial

Official title:

RECANALISATION THERAPY IN ISCHEMIC STROKE DUE TO BASILAR ARTERY OCCLUSION IN PEOPLE 115 HOSPITAL, VIETNAM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402878
• Other study ID #: People 115 Hospital
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: 115 People's Hospital
• Contact: Bich Huong Nguyen
• Phone: +84989689525
• Email: bichhuong.medic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Basilar Artery Occlusion
• Ischemic Stroke

Locations

Country	Name	City	State
Vietnam	People 115 Hospital	Ho Chi Minh	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
115 People's Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

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