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

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.

Study Overview

• Status: Recruiting
• Conditions: Basilar Artery Occlusion

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Bich Huong Nguyen; Phone Number: +84989689525; Email: bichhuong.medic@gmail.com
• Study Contact Backup: Name: Huy Thang Nguyen

Study Locations

• Vietnam
  • Ho Chi Minh City
    • Ho Chi Minh, Ho Chi Minh City, Vietnam, 70000
      • Recruiting
      • People 115 Hospital
      • Contact: Bich Huong Nguyen; Phone Number: +84989689525; Email: bichhuong.medic@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
favourable outcome	a modified Rankin Score of 0-3	90 (± 14 days) after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
good outcome	a modified Rankin Score of 0-2	90 (± 14 days) after procedure
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
Dichotomized mRS score	mRS (0-2 versus 3-6 and 0-4 versus 5-6 )	90 (± 14 days) after procedure
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
Any intracerebral hemorrhage	intracerebral hemorrhage was defined according ECASS definition.	within 72 hours after procedure
Procedural related complications	arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on	Perioperative period

Collaborators and Investigators

• Sponsor: 115 People's Hospital
• Investigators: Study Director: Huy Thang Nguyen, Professor, People 115 Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: BASILAR ARTERY OCCLUSION; RECANALISATION THERAPY
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Arterial Occlusive Diseases
• Other Study ID Numbers: People 115 Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No