Actively Recruiting
A Prospective Multicenter Registry Study on BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Led by Fujian Medical University Union Hospital · Updated on 2025-03-18
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fujian Medical University Union Hospital
Lead Sponsor
Z
Zhangzhou Municipal Hospital of Fujian Province
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the BASIS technique, a specialized balloon angioplasty combined with distal protection by a stent retriever, in treating acute large vessel occlusion strokes caused by intracranial atherosclerosis. This multicenter, prospective, observational single-arm study aims to gather detailed data on procedure times, recanalization success, complications, and patient outcomes to improve treatment methods for complex stroke lesions. The study involves using the BASIS technique during endovascular therapy, which includes balloon angioplasty under the protection of a stent retriever for blood vessel reopening. Surgeons follow a stepwise procedure involving microcatheter placement, balloon inflation, thrombus removal with suction techniques, and repeated angiographic checks to ensure clearance of blockages. The study has no control group and allows different remedial treatments as needed during the procedure. Participants will be monitored for complications such as branch occlusion, vessel dissection, rupture, thrombus displacement, and symptomatic intracranial hemorrhage. Key outcomes measured include modified Rankin Scale (mRS) scores at 90 days and first pass effect during the approximately three-hour surgery. Follow-up over three months records mortality, functional recovery, and residual vessel narrowing. The study tracks detailed intraoperative and postoperative data to assess the technique's impact on safety and prognosis.
CONDITIONS
Brief Title
A Prospective Multicenter Registry Study on BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed ischemic stroke
- Stroke symptoms started within 72 hours before the visit, including waking or blind onset strokes
- Imaging shows occlusion of large intracranial vessels with large atherosclerosis type
- Planned use of BASIS technique for intravascular therapy
You will not qualify if you...
- Acute occlusion of multiple vessels or tandem lesions on admission imaging
- History of atrial fibrillation or heart valve surgery
- Contraindications to antiplatelet drugs such as hemophilia or thrombocytopenia
- Rare coagulation disorders, platelet abnormalities, active internal bleeding, or intracranial bleeding history
- Other types of stroke, including hemorrhagic stroke
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 3 hours (from enrollment to end of surgery)
Participants undergo the BASIS technique, a balloon angioplasty with distal protection using a stent retriever to treat acute large vessel occlusion strokes due to intracranial atherosclerotic disease.
1 treatment visit (in-person)
Duration - 90 days
Participants are followed for recovery and assessment of outcomes including functional status at 90 days after treatment.
Follow-up visits as scheduled up to 90 days
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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