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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05049564
Other study ID # SJWKvascular001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2013
Est. completion date December 31, 2018

Study information

Verified date September 2021
Source Second Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Single intracranial anterior circulation aneurysm diagnosed by CTA or DSA - CT showed that subarachnoid hemorrhage originated from the rupture of the aneurysm and was confirmed during operation - No indication of decompressive craniectomy (Hunt-Hess grade = 4, Glasgow Coma Scale = 7, no brain herniation; CT showed midline displacement < 5mm) - The aneurysm is suitable for both endovascular treatment and microsurgical clipping Exclusion Criteria: - The patients and their families did not agree to join the study - Patients with unruptured anterior circulation aneurysms - Patients with posterior circulation aneurysms - Patients with multiple intracranial aneurysms - Those who cannot receive treatment due to serious concomitant diseases

Study Design


Intervention

Procedure:
keyhole microneurosurgery
microsurgical clipping via keyhole approach
conventional microneurosurgery
microsurgical clipping via conventional craniotomy
endovascular coiling
endovascular coiling via femoral approach

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
ZhuQing

Outcome

Type Measure Description Time frame Safety issue
Primary occlusion rate of aneurysm occlusion rate of aneurysm an average of 1 month
Primary operative time total operative duration an average of 1 month
Primary hospitalization time hospitalization duration up to 3 months after discharge
Primary hospitalization cost cost during hospitalization up to 3 months after discharge
Primary postoperative complication rate complication rate after intervention up to 3 months after discharge
Secondary recurrent rate of aneurysm recurrent rate after treatment of aneurysm 6 months after treatment
Secondary long-term complication rate complication rate during follow-up 6 months after treatment
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