NCT05049564

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

August 31, 2021

Last Update Submit

September 8, 2021

Conditions

Randomized Controlled TrialIntracranial AneurysmMicrosurgeryEndovascular Procedures

Outcome Measures

Primary Outcomes (5)

  • occlusion rate of aneurysm

    occlusion rate of aneurysm

    an average of 1 month

  • operative time

    total operative duration

    an average of 1 month

  • hospitalization time

    hospitalization duration

    up to 3 months after discharge

  • hospitalization cost

    cost during hospitalization

    up to 3 months after discharge

  • postoperative complication rate

    complication rate after intervention

    up to 3 months after discharge

Secondary Outcomes (2)

  • recurrent rate of aneurysm

    6 months after treatment

  • long-term complication rate

    6 months after treatment

Study Arms (3)

keyhole group

EXPERIMENTAL

patient harbored aneurysm who was treated by microsurgical clipping via keyhole approach.

Procedure: keyhole microneurosurgery

conventional group

EXPERIMENTAL

patient harbored aneurysm who was treated by microsurgical clipping via conventional craniotomy.

Procedure: conventional microneurosurgery

endovascular group

EXPERIMENTAL

patient harbored aneurysm who was treated by endovascular coiling via femoral approach.

Procedure: endovascular coiling

Interventions

keyhole microneurosurgeryPROCEDURE

microsurgical clipping via keyhole approach

keyhole group
conventional microneurosurgeryPROCEDURE

microsurgical clipping via conventional craniotomy

conventional group
endovascular coilingPROCEDURE

endovascular coiling via femoral approach

endovascular group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Qing Lan, Doctor

    Second Affiliated Hospital of Soochow University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Neurosurgeon

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 20, 2021

Study Start

January 1, 2013

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share