Safety and Efficacy of Endovascular Treatment for Acute Basilar Artery Occlusion in the Extended Time Window -a Prospective, Multicenter, Randomized Controlled, Open-label Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Posterior circulation acute ischemic stroke within 24-72 hours from symptom onset/last seen well (except for isolated vertigo), where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization.

• Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.

• Age ≥18 and ≤ 80.

• Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.

• No significant pre-stroke functional disability (mRS ≤ 1).

• Patient treatable within 72 hours of symptom onset. Symptom onset is defined as the point in time the patient was last seen well (at baseline) if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history.

• Informed consent obtained from patient or authorized patient surrogate

Locations
Other Locations
China
Xuanwu hospital
RECRUITING
Beijing
Contact Information
Primary
Xunming Ji
jixm@ccmu.edu
01083198962
Backup
Chuanhui Li
lichuanhui365@163.com
15210439828
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 309
Treatments
Experimental: mechanical thrombectomy group
Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
No_intervention: best medical management agroup
Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment.
Related Therapeutic Areas
Sponsors
Leads: Capital Medical University

This content was sourced from clinicaltrials.gov