Skip to main content
Clinical Trials/NCT04751708
NCT04751708
Completed
Not Applicable

Endovascular Treatment for Acute Basilar Artery Occlusion - a Multicenter Randomized Clinical Trial

The First Affiliated Hospital of University of Science and Technology of China1 site in 1 country340 target enrollmentFebruary 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Basilar Artery Occlusion
Sponsor
The First Affiliated Hospital of University of Science and Technology of China
Enrollment
340
Locations
1
Primary Endpoint
a modified Rankin Score of 0-3
Status
Completed
Last Updated
3 years ago

Overview

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. Besides, a recently prospective clinical registry with large sample size (BASILAR) showed a significantly beneficial effect of EVT in BAO patients.

Objective: To assess the effect of EVT in addition to best medical management (BMM) compared to BMM alone, in patients with BAO, caused by a CTA/MRA confirmed occlusion of the basilar artery on functional and safety outcome.

Study design: This is a parallel group, randomized clinical trial of EVT with BMM versus BMM. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow up.

Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA.

Main study parameters/outcomes: The primary effect parameter will be favourable outcome at day 90 defined as a modified Rankin Score (mRS) of 0-3. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

Registry
clinicaltrials.gov
Start Date
February 21, 2021
End Date
April 3, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of University of Science and Technology of China
Responsible Party
Principal Investigator
Principal Investigator

Wei Hu

Professor

The First Affiliated Hospital of University of Science and Technology of China

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

a modified Rankin Score of 0-3

Time Frame: 90 (± 14 days) after procedure

Favourable outcome at day 90 (± 14 days)

Secondary Outcomes

  • Modified Rankin Score(90 (± 14 days) after procedure)
  • mortality(90 (± 14 days) after procedure)
  • a modified Rankin Score of 0-2(90 (± 14 days) after procedure)
  • NIHSS score(5-7 days after procedure)
  • symptomatic intracerebral hemorrhage (ICH)(within 72 hours after procedure)

Study Sites (1)

Loading locations...

Similar Trials