Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416657
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Brief Title:
General Anesthesia Vs Local Anesthesia for Endovascular Treatment in Patients with Unruptured Intracranial Aneurysm Using Flow Diverter
Sponsor:
Ming Lv
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
General Anesthesia Vs Local Anesthesia for Endovascular Treatment in Patients with Unruptured Intracranial Aneurysm Using Flow Diverter an Exploratory Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None