Ignite Creation Date:
2024-05-06 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05049564
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2021-08-31
Brief Title:
Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms
Sponsor:
ZhuQing
Organization:
Second Affiliated Hospital of Soochow University
Study Overview
Official Title:
A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms
Status:
COMPLETED
Status Verified Date:
2021-09
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:
Endovascular coiling has become a strategy of choice of intracranial aneurysms due to its minimally invasiveness However there has few prospective randomized controlled studies on the comparison of therapeutic effect between endovascular coiling and microsurgical clipping especially the latter via keyhole approaches which has been widely used in recent years Based on the data of a single center a randomized controlled study was conducted on patients with ruptured anterior circulation aneurysms suitable for both endovascular and extravascular treatment including endovascular coiling microsurgical clipping via conventional craniotomy and keyhole approaches in order to compare the efficacy of the above strategies and provide more objective basis for treatment selection for operators
Detailed Description:
Consecutive patients of a single center will be screened If spontaneous subarachnoid hemorrhage SAH is confirmed by head computed tomography CT a diagnostic CT angiography CTA or digital subtraction angiography DSA will be carried out emergently A patients harbored a single intracranial aneurysm of anterior circulation that resulted in SAH will be concerned Based on the assessment of condition the patient will enrolled into this study without indication of decompressive craniectomy The enrolled patients will be divided randomly into 3 groups who experienced endovascular coiling microsurgical clipping via conventional craniotomy and via keyhole approaches All of these treatment will be conducted by a same senior neurosurgeon CTA or DSA were followed up regularly The occlusion rate operative period hospitalization duration and cost surgical complications were compared and analyzed
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