Status:
RECRUITING
A Prospective Multicenter Registry Study on BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Lead Sponsor:
Fujian Medical University Union Hospital
Collaborating Sponsors:
Zhangzhou Municipal Hospital of Fujian Province
First Affiliated Hospital of Jinan University
Conditions:
Acute Ischemic Stroke
ICAS - Intracranial Atherosclerosis
Eligibility:
All Genders
18+ years
Brief Summary
This study will explore the safety and efficacy of BASIS technology in ICAS-LVO lesions through a multicenter, prospective, registry, observational single-arm study.By registering intraoperative recan...
Detailed Description
This project intends to set up a prospective multi-center single-arm study with no control group and no upper limit of cases. Using BASIS (Balloon AngioplaSty with the dIstal protection of Stent retr...
Eligibility Criteria
Inclusion
- Age ≥18 years old;
- Ischemic stroke;
- Within 72 hours from the onset of symptoms to the time of visit, including post-awakening stroke or blindness For stroke patients, the time when symptoms start is defined as "the last normal time";
- Neuroimaging examination indicated occlusion of anterior or posterior intracranial large vessels, TOAST type was large atherosclerosis type.
- BASIS technique was used for intravascular therapy.
Exclusion
- Neuroimaging findings on admission, acute occlusion of multiple vessels and tandem lesions;
- History of atrial fibrillation or heart valve surgery;
- There are clinical contraindications to the use of antiplatelet drugs (hemophilia or thrombocytopenia).Rare disease, known history of coagulation disorders, platelet abnormalities; There is active internal bleeding, intracranial Bleeding history, arteriovenous malformation, aneurysm, etc.);
- Other types of stroke, including hemorrhagic stroke.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06881420
Start Date
January 1 2024
End Date
December 31 2025
Last Update
March 18 2025
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China