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

• Sponsor: ZhuQing (Other)
• Overall Status: Completed
• CT.gov ID: NCT05049564
• Collaborator: (none)
• Enrollment: 150
• Arms: 3
• Actual Duration (Months): 72

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Randomized Controlled Trial; Intracranial Aneurysm; Microsurgery; Endovascular Procedures	Procedure: keyhole microneurosurgery; Procedure: conventional microneurosurgery; Procedure: endovascular coiling	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Study of Microsurgical Clipping Via Keyhole Approaches Versus Traditional Open Approaches and Endovascular Coiling for Ruptured Anterior Circulation Aneurysms
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: keyhole group patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.	Procedure: keyhole microneurosurgery; microsurgical clipping via keyhole approach
Experimental: conventional group patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.	Procedure: conventional microneurosurgery; microsurgical clipping via conventional craniotomy
Experimental: endovascular group patient harbored aneurysm who was treated by endovascular coiling via femoral approach.	Procedure: endovascular coiling; endovascular coiling via femoral approach

Outcome Measures

Primary Outcome Measures

1. occlusion rate of aneurysm [an average of 1 month]

   occlusion rate of aneurysm

2. operative time [an average of 1 month]

   total operative duration

3. hospitalization time [up to 3 months after discharge]

   hospitalization duration

4. hospitalization cost [up to 3 months after discharge]

   cost during hospitalization

5. postoperative complication rate [up to 3 months after discharge]

   complication rate after intervention

Secondary Outcome Measures

1. recurrent rate of aneurysm [6 months after treatment]

   recurrent rate after treatment of aneurysm

2. long-term complication rate [6 months after treatment]

   complication rate during follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ZhuQing

Investigators

• Study Director: Qing Lan, Doctor, Second Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ZhuQing, Chief Neurosurgeon, Second Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT05049564
• Other Study ID Numbers: SJWKvascular001
• First Posted: Sep 20, 2021
• Last Update Posted: Sep 20, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

No Results Posted as of Sep 20, 2021