Intracranial AneurysmNuCATCHNCT06466564
Bioabsorbable/Nufairy Coil Application Trial in China
A study testing Nufairy® Coil embolization system for intracranial aneurysm in people with Intracranial Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
Trial summary
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Nufairy® Coil embolization system for intracranial aneurysm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2023to 1 Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;
- Intracranial aneurysm diagnosed by CTA, MRA, DSA neuroimaging examination;
- Subjects whose target aneurysms are suitable for embolization with flow diverter or intracranial arterial stents assisted by coils, and the entire treatment can be performed in a single procedure;
- The subjects or the subject's guardian signs the informed consent voluntarily and is willing to accept follow-up.
Who cannot join
- mRS Score ≥3 points in clinical assessment prior to enrollment;
- Subjects who received neurosurgical or endovascular treatment for recurrent aneurysms;
- Subjects with multiple aneurysms;
- Subjects with ruptured aneurysms <30 days;
- Significant stenosis (≥50%) of parent artery;
- Subjects who are not suitable for anesthesia or intravascular surgery, such as major diseases of the heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, and a history of serious mental illness;
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- Subjects who have undergone major surgical procedures (such as internal fixation device implantation of limbs fracture, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent or plan to undergo major surgical procedures within 60 days after signing the informed consent;
- Subjects with morphology or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, limited vascular access (e.g., severe intracranial vessel tortuosity, severe intracranial vessel spasm that does not respond to medical treatment, other anatomical or clinical changes that impede device access;
- Treatment contrainidations of coils, including but not limited to: contrainidations of digital subtraction angiography, allergy to or intolerance of contrast agents, allergy to or intolerance of anti-platelet and anticoagulant drugs required for treatment, platinum-tungsten alloy, and poly(co-glycolic acid) (PLGA);
- Pregnant or lactating women;
- Life expectancy is less than 18 months;
- Subjects participating in other drug or device studies did not meet the endpoint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Trial of Bioabsorbable/Nufairy Coil Embolization System for the Treatment of Intracranial Aneurysms
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.
Read the detailed description
Approximately 258 subjects with intracranial aneurysms would be enrolled for coiling embolization according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±90 days) postoperatively; subjects would underwent DSA imaging at surgery and at 12months (±90 days) postoperatively, and MRA imaging at 18 months (±90 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of Nufairy Coil Embolization System for coiling embolization for the treatment of intracranial aneurysms.
- Conditions
- Intracranial Aneurysm
- Being tested
- Nufairy® Coil embolization system for intracranial aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nufairy® Coil embolization system for intracranial aneurysmDevice
Nufairy® Coil embolization system for intracranial aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Bioabsorbable/Nufairy coil embolization system Receives: Device: Nufairy® Coil embolization system for intracranial aneurysm |
| Control group | Active comparator | Numen coil embolization system Receives: Device: Nufairy® Coil embolization system for intracranial aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful occlusion rate of aneurysm at 12-month post-procedure.
It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization).
Measured: 12 month
Secondary outcomes (6)
Complete occlusion rate of aneurysm at 12-month post-procedure.
The "complete occlusion rate of aneurysm" was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I (i.e., 100% aneurysm embolization).
Measured: 12 month
Recurrence rate of aneurysm at 12-month post-procedure.
The "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure.
Measured: 12 month
Retreatment rate of aneurysm at 12-month post-procedure.
The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period
Measured: 12 month
Device-related serious adverse events at 1, 6, and 12 months after surgery;
Measured: 12 month
The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 12 months.
Measured: 12 month
The incidence of ipsilateral ischemic stroke of the target aneurysm within 12 months.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start24 Dec 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion1 Jun 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466564
- Sponsor's protocol ID
- SSTH-2023-02-0A
- Acronym
- NuCATCH
- Status last verified
- Jun 2024
- First submitted
- 4 Mar 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Trial of Bioabsorbable/Nufairy Coil Embolization System for the Treatment of Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT06466564
- Acronym / sponsor ID
- NuCATCH / SSTH-2023-02-0A
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 20 Jun 2024 (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.
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.
Detailed description
Approximately 258 subjects with intracranial aneurysms would be enrolled for coiling embolization according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±90 days) postoperatively; subjects would underwent DSA imaging at surgery and at 12months (±90 days) postoperatively, and MRA imaging at 18 months (±90 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of Nufairy Coil Embolization System for coiling embolization for the treatment of intracranial aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Nufairy® Coil embolization system for intracranial aneurysmBioabsorbable/Nufairy coil embolization system |
| Control group | Active comparator | Device: Nufairy® Coil embolization system for intracranial aneurysmNumen coil embolization system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;
- Intracranial aneurysm diagnosed by CTA, MRA, DSA neuroimaging examination;
- Subjects whose target aneurysms are suitable for embolization with flow diverter or intracranial arterial stents assisted by coils, and the entire treatment can be performed in a single procedure;
- The subjects or the subject's guardian signs the informed consent voluntarily and is willing to accept follow-up.
Key exclusion criteria (12 listed)
- mRS Score ≥3 points in clinical assessment prior to enrollment;
- Subjects who received neurosurgical or endovascular treatment for recurrent aneurysms;
- Subjects with multiple aneurysms;
- Subjects with ruptured aneurysms <30 days;
- Significant stenosis (≥50%) of parent artery;
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 |
|---|---|---|
| Nufairy® Coil embolization system for intracranial aneurysmNufairy® Coil embolization system for intracranial aneurysm | Device | Control group, Experimental group |
Primary outcome
Successful occlusion rate of aneurysm at 12-month post-procedure.
Time frame: 12 month
It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization).
6 secondary outcomes
Complete occlusion rate of aneurysm at 12-month post-procedure.
Time frame: 12 month
Recurrence rate of aneurysm at 12-month post-procedure.
Time frame: 12 month
Retreatment rate of aneurysm at 12-month post-procedure.
Time frame: 12 month
Device-related serious adverse events at 1, 6, and 12 months after surgery;
Time frame: 12 month
The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 12 months.
Time frame: 12 month
The incidence of ipsilateral ischemic stroke of the target aneurysm within 12 months.
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
Jianmin Liu principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nufairy® Coil embolization system for intracranial aneurysm in people with Intracranial Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
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 4 inclusion and 12 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Successful occlusion rate of aneurysm at 12-month post-procedure. (time frame: 12 month). 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 20 Jun 2024.