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