Intracranial Artery StenosisNCT07170618
Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis
A study testing balloon microcatheter in people with Intracranial Artery Stenosis, run by Sinomed Neurovita Technology Inc. at 1 site in China.
Trial summary
The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Artery Stenosis
- What is being tested?
- balloon microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 to 80 years of age
- Patients with intracranial artery stenosis (Degree of stenosis: ≥70%)
- Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm
- Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives
Who cannot join
- The proximal end of the target vessel is extremely tortuous, severely angulated, or heavily calcified, making it difficult for the device to reach the target vessel
- Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders
- Disabling stroke with a baseline mRS score ≥ 3 points
- Non-atherosclerosis diseases
- Patients with stroke caused by branch occlusion
- Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint
- Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents
- Investigators consider the patient who is not suitable for enrolling in the present trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin
Yong Li Li, 13904611005, liyongli9999@163.com
About this study
Official title: A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of a Balloon Microcatheter for Clinical Use
The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
Read the detailed description
This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of a balloon microcatheter in the treatment of intracranial artery stenosis. A total of 56 patients are planned to be included. The endpoints include device success, target vessel dissection, target vessel occlusion, mortality and cerebrovascular events, assessed during the in-hospital until discharge.
- Conditions
- Intracranial Artery Stenosis
- Being tested
- balloon microcatheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon microcatheterDevice
The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.
| Study group | Role | What they receive |
|---|---|---|
| balloon microcatheter | Experimental | For the treatment of intracranial artery stenosis, balloon microcatheter would combine the advantages of balloon dilatation first and then, if necessary, the additional deployment of a self-expandable stent via the same balloon microcatheter lumen. Receives: Device: balloon microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device success
The system was successfully delivered to the target site, the balloon was successfully inflated at the lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.
Measured: During interventional procedure
Secondary outcomes (5)
Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke.
Measured: Perioperatively (During the in-hospital until discharge)
Rate of target vessel dissection, target vessel occlusion
Number of patients with dissection or occlusion of the target vessel
Measured: Perioperatively (During interventional procedure)
Mortality
The proportion of patients who died during the in-hospital until discharge
Measured: Perioperatively (During the in-hospital until discharge)
Proportion of adverse events or severe adversary event
The proportion of adverse events or severe adverse event
Measured: Perioperatively (During the in-hospital until discharge)
Incidence of device defects
The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
Measured: Perioperatively (During the in-hospital until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Artery StenosisStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinomed Neurovita Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170618
- Sponsor's protocol ID
- SINOMED-BMC-2025
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of a Balloon Microcatheter for Clinical Use
- ClinicalTrials.gov ID
- NCT07170618
- Acronym / sponsor ID
- SINOMED-BMC-2025
- Conditions
- Intracranial Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sinomed Neurovita Technology Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Sep 2025 (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 primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
Detailed description
This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of a balloon microcatheter in the treatment of intracranial artery stenosis. A total of 56 patients are planned to be included. The endpoints include device success, target vessel dissection, target vessel occlusion, mortality and cerebrovascular events, assessed during the in-hospital until discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| balloon microcatheter | Experimental | Device: balloon microcatheterFor the treatment of intracranial artery stenosis, balloon microcatheter would combine the advantages of balloon dilatation first and then, if necessary, the additional deployment of a self-expandable stent via the same balloon microcatheter lumen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 80 years of age
- Patients with intracranial artery stenosis (Degree of stenosis: ≥70%)
- Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm
- Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives
Key exclusion criteria (8 listed)
- The proximal end of the target vessel is extremely tortuous, severely angulated, or heavily calcified, making it difficult for the device to reach the target vessel
- Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders
- Disabling stroke with a baseline mRS score ≥ 3 points
- Non-atherosclerosis diseases
- Patients with stroke caused by branch occlusion
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 |
|---|---|---|
| balloon microcatheterThe balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions. | Device | balloon microcatheter |
Primary outcome
Rate of device success
Time frame: During interventional procedure
The system was successfully delivered to the target site, the balloon was successfully inflated at the lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.
5 secondary outcomes
Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke.
Time frame: Perioperatively (During the in-hospital until discharge)
Rate of target vessel dissection, target vessel occlusion
Time frame: Perioperatively (During interventional procedure)
Mortality
Time frame: Perioperatively (During the in-hospital until discharge)
Proportion of adverse events or severe adversary event
Time frame: Perioperatively (During the in-hospital until discharge)
Incidence of device defects
Time frame: Perioperatively (During the in-hospital until discharge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon microcatheter in people with Intracranial Artery Stenosis, run by Sinomed Neurovita Technology Inc. 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 8 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: opening soon, as of the sponsor's last update on 12 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Li Li (13904611005, liyongli9999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device success (time frame: During interventional procedure). 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 12 Sep 2025.