Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560203
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAOCHE2
Brief 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
Detailed Description:
This trial aims to evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects presenting with stroke due to basilar artery occlusion in the extended time window of 24-72 hours from symptom onset or time last seen well In this trial the randomization will employ a 21 ratio of mechanical thrombectomy versus best medical management alone Randomization will be stratified according to age 18-70 or 70 baseline NIHSS 6-20 or 20 and therapeutic window 24-48 hours or 48 hours For the primary endpoint subjects will be followed for 90 days post-randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None