Basilar Artery Occlusion Chinese Endovascular Registry in Patients With Large-Core Infarct (BAOCHE-LC)
Endovascular Versus Medical Therapy for Acute Large-Core Basilar Artery Occlusion: A Multicenter Retrospective Registry Study (BAOCHE-LC)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Chuanhui Li
- Phone Number: 15210439828
- Email: lichuanhui@xwh.ccmu.edu.cn
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100053
- Xuanwu Hospital
-
Contact:
- Chuanhui Li
- Phone Number: 15210439828
- Email: lichuanhui@xwh.ccmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years, men or women.
- Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
- Time from symptom onset (or last known well) to treatment (endovascular therapy or medical therapy) ≤7 days.
- Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 0-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
Exclusion Criteria:
- Subjects with occlusions in both anterior and posterior circulation.
- CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
- Missing key clinical information (e.g., unavailable baseline NIHSS, unclear symptom onset/last known well time, or missing major treatment information including whether EVT was performed).
- Baseline NIHSS score <6.
- Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
- Missing follow-up outcomes at 90 days.
- Any other condition judged by investigators to substantially affect analysis or interpretation.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Endovascular Therapy
|
Endovascular therapy performed as part of routine clinical care for acute basilar artery occlusion, including mechanical thrombectomy with stent retriever and/or aspiration.
Rescue angioplasty and/or intracranial stenting may be used at the operator's discretion.
Peri-procedural management and concomitant medical therapy follow local standard practice.
|
|
Best Medical Treatment Alone
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Patients Achieving mRS 0-3 at 90 Days
Time Frame: 90 days
|
The modified Rankin scale (range, 0 [no symptoms] to 6 [death]).
Higher scores mean a worse outcome.
|
90 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ordinal Shift analysis of mRS at 90 days
Time Frame: 90 days
|
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
|
90 days
|
|
Proportion of Patients Achieving mRS 0-3 at 1 year
Time Frame: 1 year
|
The modified Rankin scale (range, 0 [no symptoms] to 6 [death]).
Higher scores mean a worse outcome.
|
1 year
|
|
Rate of All-Cause Mortality at 90 Days
Time Frame: 90 days
|
Death from any cause within 90 days.
|
90 days
|
|
Rate of Symptomatic Intracranial Hemorrhage
Time Frame: 24 (-2/+12) hours
|
24 (-2/+12) hours
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- BAOCHE-LC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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