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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
ZhuQing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Randomized Controlled Trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 31, 2021
    Last Updated
    September 8, 2021
    Sponsor
    ZhuQing
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    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

    Learn more about this trial

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

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