Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Endovascular Thrombectomy on Acute Basilar Artery Occlusion - a Multicenter, Randomized Controlled, Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes.

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

• Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery;

• Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion;

• Patient's age ≥ 18 years;

• Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;

• Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria;

• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10;

• The patient or patient's legal representative signs the informed consent form.

Locations
Other Locations
China
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Contact Information
Primary
Wei Hu, MD
andinghu@ustc.edu.cn
+8615155510611
Time Frame
Start Date: 2023-05-09
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 338
Treatments
Experimental: Endovascular thrombectomy alone
Patients will receive endovascular thrombectomy without intravenous thrombolysis.
Active_comparator: Intravenous thrombolysis plus endovascular thrombectomy
Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of University of Science and Technology of China

This content was sourced from clinicaltrials.gov