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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05049564
Enrollment
150
Registered
2021-09-20
Start date
2013-01-01
Completion date
2018-12-31
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Randomized Controlled Trial, Intracranial Aneurysm, Microsurgery, Endovascular Procedures

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.

Interventions

PROCEDUREkeyhole microneurosurgery

microsurgical clipping via keyhole approach

PROCEDUREconventional microneurosurgery

microsurgical clipping via conventional craniotomy

endovascular coiling via femoral approach

Sponsors

ZhuQing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
operative timean average of 1 monthtotal operative duration
hospitalization costup to 3 months after dischargecost during hospitalization
postoperative complication rateup to 3 months after dischargecomplication rate after intervention
occlusion rate of aneurysman average of 1 monthocclusion rate of aneurysm
hospitalization timeup to 3 months after dischargehospitalization duration

Secondary

MeasureTime frameDescription
long-term complication rate6 months after treatmentcomplication rate during follow-up
recurrent rate of aneurysm6 months after treatmentrecurrent rate after treatment of aneurysm

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026