Comparing general and local anesthesia for treating unruptured brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of using general anesthesia versus local anesthesia during the placement of flow diverters for treating unruptured intracranial aneurysms. The study aims to determine if local anesthesia can be a viable alternative to general anesthesia, which is currently the standard practice. Participants will be adults aged 18 to 75 with specific criteria related to their aneurysms, and the trial will assess technical success rates and complication rates associated with each anesthesia method.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Linggen Dong, MD
• Email: donglinggen@163.com
• Phone: 18844738529

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Flow Diverter Stent for Intracranial Aneurysm in China

  This study tests a novel flow diverter stent to treat intracranial aneurysms in adults and follows patients through treatment and follow-up.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07821957

• Real-World Experience With the WEB Device for Intracranial Aneurysms

  This study tests how well the Woven EndoBridge device works in routine treatment of intracranial aneurysms in China across multiple centers.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07620626

• Choydar flow-directed mesh stent for unruptured brain aneurysms

  This trial tests the Choydar flow-directed mesh stent to see if it is safe and works for people with unruptured intracranial aneurysms in the internal carotid or vertebral arteries.

  Recruiting at 8 sites Johnson & Johnson Medical (Shanghai) Ltd. · Chenzhou and 7 other locations · NCT07228312

• Pivotal test of the Silk Vista Baby Flow Diverter for unruptured brain aneurysms

  This study tests whether the Silk Vista Baby flow diverter can safely and effectively treat a single unruptured intracranial aneurysm in adults 22–80 years old.

  Recruiting at 6 sites Balt USA · Thousand Oaks, California and 5 other locations · NCT07225075

• Pipeline Vantage post-approval safety and outcomes for intracranial aneurysm treatment

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  Recruiting at 10 sites Medtronic Neurovascular Clinical Affairs · Jacksonville, Florida and 9 other locations · NCT06604884

• Improving brain intervention planning using vascular mapping

  This study is testing new ways to plan brain surgeries for aneurysms and AVMs to make them safer and more effective by using advanced mapping and computer models.

  Recruiting University Hospital, Ghent · Ghent · NCT06588543

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.