NCT05049564

Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms

A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: ZhuQing · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Randomized Controlled Trial
• Intracranial Aneurysm
• Microsurgery
• Endovascular Procedures

Interventions

Type	Name	Description
PROCEDURE	keyhole microneurosurgery	microsurgical clipping via keyhole approach
PROCEDURE	conventional microneurosurgery	microsurgical clipping via conventional craniotomy
PROCEDURE	endovascular coiling	endovascular coiling via femoral approach

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-12-31
• Completion: 2018-12-31
• First posted: 2021-09-20
• Last updated: 2021-09-20