Brain DiseasesPROMISENCT05275296
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
A study testing Intracranial stent for wide-necked aneurysms in people with Brain Diseases and Aneurysm, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
Trial summary
A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Diseases, Aneurysm, Intracranial Aneurysm
- What is being tested?
- Intracranial stent for wide-necked aneurysms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2022to 31 Dec 2023
- 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
- At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years;
- Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio <2) by DSA/CTA/MRA；
- The diameter of the parent vessel should be 2.0 to 4.5mm;
- The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation;
- Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.
Who cannot join
- Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment;
- Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery;
- Subject with multiple aneurysms that cannot be treated by single stent;
- Subject with aneurysm ruptured within 30 days;
- Subject who is not suitable for anesthesia or endovascular surgery;
- Subject with significant stenosis of the parent arterty(>50%)
Show all 13Show fewer
- Subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the ICF or would underwent major sugical procedure 60 days after signing the ICF;
- Subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device;
- Subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc;
- Subject who is contraindicated with stent-assisted coiling:
- Subject with allergy to required anti-platelet and/or heparin medications required for treatment; Subject with allergy to radiographic contrast; Subject with allergy to Nitinol, platinum-tungsten, platinum-iridium alloy.
- Women who is pregnant or now breastfeeding;
- Subject with a life expectancy less than 12 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Sheng Guan, gsradio@126.com
About this study
Official title: Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Cotrolled Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms
- Being tested
- Intracranial stent for wide-necked aneurysms
- Medical subject headings
- Brain Diseases, Aneurysm, Intracranial Aneurysm, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial stent for wide-necked aneurysmsDevice
Intracranial stent for wide-necked aneurysms
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Microport NeuroTech Intracranial Visualized Stent Receives: Device: Intracranial stent for wide-necked aneurysms |
| control group | Active comparator | LVIS™ and LVIS™ Jr Receives: Device: Intracranial stent for wide-necked aneurysms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate occlusion rate of aneurysms
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II.
Measured: Time Frame: 360±60 days
Secondary outcomes (8)
Complete occlusion rate of aneurysms
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Complete occlusion rate includes Class I
Measured: Time Frame: 360±30 days
Retreatment rate
Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up
Measured: Time Frame: 360±30 days
Successful stent placement
Successful stent placement was defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.
Measured: Intraoperation
Incidence od in-stent stenosis (≥50%)
Measured: Time Frame: 360±30 days
Incidence of device-relared stroke or death
Measured: perioperative
Incidence of ipsilateral stroke of neurological death
Measured: Time Frame: 360±30 days
Incidence of device-related severe adverse event
Measured: Time Frame: 360±30 days
Incidence of aneurysm rupture
Measured: Time Frame: 360±30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start24 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275296
- Sponsor's protocol ID
- Mermaid-2021-01-A
- Acronym
- PROMISE
- Status last verified
- Feb 2022
- First submitted
- 2 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Cotrolled Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT05275296
- Acronym / sponsor ID
- PROMISE / Mermaid-2021-01-A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Mar 2022 (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.
A registration trial of the Intracranial Visualized stent in the treatment of wide-necked 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: Intracranial stent for wide-necked aneurysmsMicroport NeuroTech Intracranial Visualized Stent |
| control group | Active comparator | Device: Intracranial stent for wide-necked aneurysmsLVIS™ and LVIS™ Jr |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years;
- Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio <2) by DSA/CTA/MRA；
- The diameter of the parent vessel should be 2.0 to 4.5mm;
- The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation;
- Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.
Key exclusion criteria (13 listed)
- Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment;
- Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery;
- Subject with multiple aneurysms that cannot be treated by single stent;
- Subject with aneurysm ruptured within 30 days;
- Subject who is not suitable for anesthesia or endovascular surgery;
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 |
|---|---|---|
| Intracranial stent for wide-necked aneurysmsIntracranial stent for wide-necked aneurysms | Device | control group, experimental group |
Primary outcome
Adequate occlusion rate of aneurysms
Time frame: Time Frame: 360±60 days
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II.
8 secondary outcomes
Complete occlusion rate of aneurysms
Time frame: Time Frame: 360±30 days
Retreatment rate
Time frame: Time Frame: 360±30 days
Successful stent placement
Time frame: Intraoperation
Incidence od in-stent stenosis (≥50%)
Time frame: Time Frame: 360±30 days
Incidence of device-relared stroke or death
Time frame: perioperative
Incidence of ipsilateral stroke of neurological death
Time frame: Time Frame: 360±30 days
Incidence of device-related severe adverse event
Time frame: Time Frame: 360±30 days
Incidence of aneurysm rupture
Time frame: Time Frame: 360±30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracranial stent for wide-necked aneurysms in people with Brain Diseases and 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 5 inclusion and 13 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 11 Mar 2022. 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?
Contact Huina Lu (15901703529, HuiNa.Lu@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate occlusion rate of aneurysms (time frame: Time Frame: 360±60 days). 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 11 Mar 2022.