Back to resultsThe 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
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
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
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
NCT ID
NCT05060185
First Posted
September 14, 2021
Last Updated
September 27, 2021
Sponsor
Jiangsu CED Medtech Co., Ltd
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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