Intracranial AneurysmNCT05060185
The Flow Diverter for Treating Patients With Intracranial Aneurysms
A study testing the Flow Diverter in people with Intracranial Aneurysm, run by Jiangsu CED Medtech Co., Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- the Flow Diverter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ●≥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
Who cannot join
- 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)
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- 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
About this study
Official title: A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms
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
- Conditions
- Intracranial Aneurysm
- Being tested
- the Flow Diverter
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Flow DiverterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | the patients will be treated by the trial device Receives: Device: the Flow Diverter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Twelve months after surgery
Secondary outcomes (3)
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.
Measured: Immediately after
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
Measured: Twelve months after surgery
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.
Measured: Twelve months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start17 Oct 2021 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu CED Medtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060185
- Sponsor's protocol ID
- CER-A-FD-01
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT05060185
- Acronym / sponsor ID
- CER-A-FD-01
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Jiangsu CED Medtech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2021 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Device: the Flow Diverterthe patients will be treated by the trial device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ●≥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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Flow DiverterThose 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. | Device | single arm |
Primary outcome
The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging
Time frame: Twelve months after surgery
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
3 secondary outcomes
Immediate postoperative success rate
Time frame: Immediately after
The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed
Time frame: Twelve months after surgery
The rate of self-care (mRS 0-2 points) at 12 months after operation
Time frame: Twelve months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing the Flow Diverter in people with Intracranial Aneurysm, run by Jiangsu CED Medtech Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging (time frame: Twelve months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.