Actively Recruiting
General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter
Led by Ming Lv · Updated on 2025-12-02
188
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Ming Lv
Lead Sponsor
B
Beijing Chao Yang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.
CONDITIONS
Official Title
General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, any gender
- Untreated unruptured intracranial aneurysm diagnosed by DSA, CTA, or MRA
- Maximum aneurysm diameter less than 15 mm
- Baseline mRS score of 2 or lower
- Planned treatment with Pipeline Embolization Device (PED)
- Voluntary participation with signed informed consent
You will not qualify if you...
- Aneurysms located distal to the anterior cerebral artery, M2 segment of middle cerebral artery, or basilar artery
- Allergy to any components of the anesthetic drugs
- Severe symptoms related to the aneurysm with mRS score 3 or higher
- Pregnant or lactating females
- Severe liver dysfunction (ALT or AST more than three times normal limits) or severe kidney dysfunction (creatinine clearance less than 30 mL/min)
- Presence of metal implants such as cardiac stents, prosthetic valves, pacemakers, metal joints, steel plates, or non-removable metal dentures
- Dementia, psychiatric diseases, or claustrophobia preventing MRI completion
- Other serious diseases with expected survival less than 1 year
- Participation in other clinical trials of drugs or devices
- Any condition judged unsuitable for enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
L
Linggen Dong, MD
CONTACT
M
Ming Lv, Ph D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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