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The Flow Diverter for Treating Patients With Intracranial Aneurysms

Primary Purpose

Intracranial Aneurysm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the Flow Diverter
Sponsored by
Jiangsu CED Medtech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

●≥18 years old and ≤75 years old, male or unpregnant female

  • Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm was defined as the tumor neck ≥4mm or the tumor body/tumor neck ratio <2)
  • The target aneurysm is planned to be treated with blood flow guidance device only, without the need to complete the treatment by stages
  • The width of tumor neck should be less than 30mm
  • Imaging measurements of the tumor parent artery showed that the diameter was 1.5mm ~ 6.5mm
  • The subject or legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent

Exclusion Criteria:

  • The target aneurysm has previously received craniotomy clipping or other endovascular interventional treatment
  • Target aneurysms were haemacular aneurysms, pseudoaneurysms, arteriovenous malformations and moyamoya disease related aneurysms
  • DSA suggested vascular path tortuosity or severe arteriosclerosis, and it was difficult for the instrument to reach the target vessel
  • Contraindications to dual antiplatelet therapy and anticoagulation therapy
  • Patients with known clear allergy to nickel-titanium alloys and platinum-tungsten alloys
  • People with known severe allergy to contrast media (excluding rash)
  • patients with known dementia or mental illness
  • Preoperative complicated with serious heart, liver, kidney, respiratory system diseases and bleeding disorders
  • Life expectancy is less than one year
  • Is participating in, or may participate in, any other drug or medical device clinical trial after inclusion in this clinical trial
  • Other conditions determined by the investigator to be unsuitable for participation in this clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    single arm

    Arm Description

    the patients will be treated by the trial device

    Outcomes

    Primary Outcome Measures

    The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging
    The cerebral vascular imaging examination 12 months after the operation was performed to analyze whether the aneurysm was completely occluded. Aneurysm occlusion images were reviewed by clinicians and the core laboratory respectively. When the evaluation results were different from those determined by clinicians, the results of the core laboratory should prevail

    Secondary Outcome Measures

    Immediate postoperative success rate
    The intraoperative blood flow guidance device was successfully released, and the implant was accurately located by angiography after placement, and the proportion of subjects who could effectively cover aneurysma neck was calculated.
    The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed
    The clinician and the core laboratory will evaluate the results respectively. If the evaluation results are different from those determined by the clinician, the core laboratory results shall prevail
    The rate of self-care (mRS 0-2 points) at 12 months after operation
    MRS is a disability assessment to assess the independent living standard of postoperative patients and analyze the outcome of aneurysm surgery.

    Full Information

    First Posted
    September 14, 2021
    Last Updated
    September 27, 2021
    Sponsor
    Jiangsu CED Medtech Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05060185
    Brief Title
    The Flow Diverter for Treating Patients With Intracranial Aneurysms
    Official Title
    A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 17, 2021 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu CED Medtech Co., Ltd

    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
    To evaluate the efficacy and safety of the blood flow guide device manufactured by Jiangsu Changyida Medical Technology Co., Ltd. for endovascular embolization of intracranial aneurysms

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Aneurysm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    166 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single arm
    Arm Type
    Other
    Arm Description
    the patients will be treated by the trial device
    Intervention Type
    Device
    Intervention Name(s)
    the Flow Diverter
    Intervention Description
    Those who meet the inclusion criteria but do not meet the exclusion criteria will be enrolled through the electronic central registration system. The investigator log in to the central registration system, fill in the subject information and submit it who enroll in the study. The investigator complete the surgery and conduct relevant evaluation according to the protocol.
    Primary Outcome Measure Information:
    Title
    The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging
    Description
    The cerebral vascular imaging examination 12 months after the operation was performed to analyze whether the aneurysm was completely occluded. Aneurysm occlusion images were reviewed by clinicians and the core laboratory respectively. When the evaluation results were different from those determined by clinicians, the results of the core laboratory should prevail
    Time Frame
    Twelve months after surgery
    Secondary Outcome Measure Information:
    Title
    Immediate postoperative success rate
    Description
    The intraoperative blood flow guidance device was successfully released, and the implant was accurately located by angiography after placement, and the proportion of subjects who could effectively cover aneurysma neck was calculated.
    Time Frame
    Immediately after
    Title
    The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed
    Description
    The clinician and the core laboratory will evaluate the results respectively. If the evaluation results are different from those determined by the clinician, the core laboratory results shall prevail
    Time Frame
    Twelve months after surgery
    Title
    The rate of self-care (mRS 0-2 points) at 12 months after operation
    Description
    MRS is a disability assessment to assess the independent living standard of postoperative patients and analyze the outcome of aneurysm surgery.
    Time Frame
    Twelve months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ●≥18 years old and ≤75 years old, male or unpregnant female Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm was defined as the tumor neck ≥4mm or the tumor body/tumor neck ratio <2) The target aneurysm is planned to be treated with blood flow guidance device only, without the need to complete the treatment by stages The width of tumor neck should be less than 30mm Imaging measurements of the tumor parent artery showed that the diameter was 1.5mm ~ 6.5mm The subject or legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent Exclusion Criteria: The target aneurysm has previously received craniotomy clipping or other endovascular interventional treatment Target aneurysms were haemacular aneurysms, pseudoaneurysms, arteriovenous malformations and moyamoya disease related aneurysms DSA suggested vascular path tortuosity or severe arteriosclerosis, and it was difficult for the instrument to reach the target vessel Contraindications to dual antiplatelet therapy and anticoagulation therapy Patients with known clear allergy to nickel-titanium alloys and platinum-tungsten alloys People with known severe allergy to contrast media (excluding rash) patients with known dementia or mental illness Preoperative complicated with serious heart, liver, kidney, respiratory system diseases and bleeding disorders Life expectancy is less than one year Is participating in, or may participate in, any other drug or medical device clinical trial after inclusion in this clinical trial Other conditions determined by the investigator to be unsuitable for participation in this clinical trial

    12. IPD Sharing Statement

    Learn more about this trial

    The Flow Diverter for Treating Patients With Intracranial Aneurysms

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