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RecruitingNCT05827042

Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
338 (estimated)
Sponsor
The First Affiliated Hospital of University of Science and Technology of China · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Two recent randomized, controlled trials from China-ATTENTION (Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion) and BAOCHE (Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion) have shown a significantly beneficial effect of endovascular thrombectomy in patients with an acute symptomatic basilar artery occlusion. The DEVT (Direct Endovascular Treatment versus Standard Bridging Therapy for Acute Stroke Patients with Large Vessel Occlusion in The Anterior Circulation) and DIRECT-MT (Direct Intraarterial Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals Trial) trials showed that endovascular thrombectomy alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. However, it is unclear whether endovascular thrombectomy alone is noninferior to intravenous thrombolysis bridging with endovascular thrombectomy for achieving functional independence at 90 days among patients with acute basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of endovascular thrombectomy alone in these patients.

Conditions

Interventions

TypeNameDescription
DRUGIntravenous thrombolysisPatients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.
PROCEDUREEndovascular thrombectomyEndovascular thrombectomy

Timeline

Start date
2023-05-09
Primary completion
2025-12-31
Completion
2026-03-31
First posted
2023-04-24
Last updated
2024-10-01

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05827042. Inclusion in this directory is not an endorsement.