Endovascular Treatment for Acute Basilar Artery Occlusion

Not Applicable

Completed

• Conditions: Acute Cerebrovascular Accident; Stroke Due to Basilar Artery Occlusion; Basilar Artery Occlusion
• Interventions: Other: best medical management; Procedure: endovascular treatment

• Registration Number: NCT04751708
• Lead Sponsor: The First Affiliated Hospital of University of Science and Technology of China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-12
• Study Start: 2021-02-21
• Primary Completion: 2022-01-03
• Study Completion: 2022-04-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
best medical management	best medical management	Unless contra-indicated patients are treated with a standard full dose of open-label IV rt-PA (0.9mg/kg; 90mg maximum). IVT has to be initiated within 4.5 hours of estimated time of basilar artery occlusion. For the patients in whom the rtPA is contraindicated, the standard medical treatment follows the current guidelines for the early management of patients with acute ischemic stroke from the American Heart Association/American Stroke Association.
endovascular treatment+ best medical management	endovascular treatment	Device: endovascular treatment For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.

Primary Outcome Measures

Name	Time	Method
a modified Rankin Score of 0-3	90 (± 14 days) after procedure	Favourable outcome at day 90 (± 14 days)

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Score	90 (± 14 days) after procedure	The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability.
mortality	90 (± 14 days) after procedure	(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%
a modified Rankin Score of 0-2	90 (± 14 days) after procedure	Excellent outcome
NIHSS score	5-7 days after procedure	The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
symptomatic intracerebral hemorrhage (ICH)	within 72 hours after procedure	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine; 🇨🇳 Hefei, Anhui, China