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General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter

RecruitingNAAges 18 Years - 80 YearsAllMing Lv
NCT06416657 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years old and ≤80 years old, gender is not limited; 2. Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA; 3. UIA maximum diameter \<15mm; 4. Baseline mRS score ≤2; 5. UIAs planned for treated with PED; 6. Patients voluntarily participated in this study and signed an informed consent form. Exclusion Criteria: 1. The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery; 2. Those who are allergic to any components of the anesthetic drugs; 3. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3; 4. Pregnant and lactating female patients; 5. Severe hepatic dysfunction (ALT or AST \>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \<30 mL/min) before randomisation; 6. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.); 7. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination; 8. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year; 9. Patients who are participating in clinical trials of other drugs or devices; 10. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.
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What it tests

  • Different anesthesia methods, namely local anesthesia and general anesthesia
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Where

1 site
Beijing Tiantan Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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