Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms
Primary Purpose
Randomized Controlled Trial, Intracranial Aneurysm, Microsurgery
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
keyhole microneurosurgery
conventional microneurosurgery
endovascular coiling
Sponsored by
About this trial
This is an interventional treatment trial for Randomized Controlled Trial
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
keyhole group
conventional group
endovascular group
Arm Description
patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.
patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.
patient harbored aneurysm who was treated by endovascular coiling via femoral approach.
Outcomes
Primary Outcome Measures
occlusion rate of aneurysm
occlusion rate of aneurysm
operative time
total operative duration
hospitalization time
hospitalization duration
hospitalization cost
cost during hospitalization
postoperative complication rate
complication rate after intervention
Secondary Outcome Measures
recurrent rate of aneurysm
recurrent rate after treatment of aneurysm
long-term complication rate
complication rate during follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05049564
Brief Title
Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms
Official Title
A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ZhuQing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Randomized Controlled Trial, Intracranial Aneurysm, Microsurgery, Endovascular Procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
keyhole group
Arm Type
Experimental
Arm Description
patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.
Arm Title
conventional group
Arm Type
Experimental
Arm Description
patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.
Arm Title
endovascular group
Arm Type
Experimental
Arm Description
patient harbored aneurysm who was treated by endovascular coiling via femoral approach.
Intervention Type
Procedure
Intervention Name(s)
keyhole microneurosurgery
Intervention Description
microsurgical clipping via keyhole approach
Intervention Type
Procedure
Intervention Name(s)
conventional microneurosurgery
Intervention Description
microsurgical clipping via conventional craniotomy
Intervention Type
Procedure
Intervention Name(s)
endovascular coiling
Intervention Description
endovascular coiling via femoral approach
Primary Outcome Measure Information:
Title
occlusion rate of aneurysm
Description
occlusion rate of aneurysm
Time Frame
an average of 1 month
Title
operative time
Description
total operative duration
Time Frame
an average of 1 month
Title
hospitalization time
Description
hospitalization duration
Time Frame
up to 3 months after discharge
Title
hospitalization cost
Description
cost during hospitalization
Time Frame
up to 3 months after discharge
Title
postoperative complication rate
Description
complication rate after intervention
Time Frame
up to 3 months after discharge
Secondary Outcome Measure Information:
Title
recurrent rate of aneurysm
Description
recurrent rate after treatment of aneurysm
Time Frame
6 months after treatment
Title
long-term complication rate
Description
complication rate during follow-up
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Lan, Doctor
Organizational Affiliation
Second Affiliated Hospital of Soochow University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms
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