Cerebral Atherosclerotic StenosisNCT06683118
Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis
A study testing Rapamycin neurovascular Balloon Catheter and Conventional Balloon in people with Cerebral Atherosclerotic Stenosis, run by MicroPort NeuroTech Co., Ltd. at 2 sites in China.
Trial summary
The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Atherosclerotic Stenosis
- What is being tested?
- Rapamycin neurovascular Balloon Catheter and Conventional Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesChina
- Study dates
- 27 May 2024to 27 Jul 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
None listed.
Who cannot join
- History of acute ischemic stroke within 2 weeks;
- Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
- Target vessels complete occlusion or with thrombus in target vessels;
- Target vessel with severe calcification or distortion that making interventional device is difficult to place;
- History of stenting in the target artery;
- Target vessel restenosis following stenting or balloon angioplasty;
Show all 17Show fewer
- Combined with other lesion with ≥70% stenosis in target vessel.
- Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation.
- Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel.
- History of intracranial hemorrhage within 90days.
- Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction;
- Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders;
- Allergic to contrast agents or rapamycin;
- Pregnant or lactating women;
- Participating or intending to participate in any other drug/device clinical trials;
- Life expectancy <1 year;
- Any other conditions that the investigator deems the patient unsuitable for enrollment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Tiantan Hospital Affiliated of Peking University
Beijing, Beijing Municipality
Huashan Hospital Affiliated of Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS
The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
- Conditions
- Cerebral Atherosclerotic Stenosis
- Being tested
- Rapamycin neurovascular Balloon Catheter, Conventional Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin neurovascular Balloon CatheterDevice
Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis
Conventional BalloonDevice
Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Device: Rapamycin neurovascular Balloon Catheter |
| control group | Active comparator | Not described Receives: Device: Conventional Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion restenosis rate at 6 month postoperative
The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method.
Measured: 180±30days
Secondary outcomes (7)
Technical succeed rate
defined as smooth delivery of the device to the target lesion and successful dilatation, unloading, and retraction
Measured: Intraoperation
Target vascular-related stroke or death at 30 days postoperatively
Measured: 30±7days
Any stroke or death at 30 days postoperatively
Measured: 30±7days
Target vascular-related stroke or death at 6 month postoperatively
Measured: 180±30days
Any stroke or death at 6 month postoperatively
Measured: 180±30days
Target vascular-related stroke or death at 12 month postoperatively
Measured: 360±60days
Any stroke or death at 12 month postoperatively
Measured: 360±60days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start27 May 2024
- Primary completion27 Jul 2025 (estimated)
- Study completion27 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Atherosclerotic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 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
- NCT06683118
- Sponsor's protocol ID
- JUJI-2023-01-CIP-00
- Status last verified
- Aug 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS
- ClinicalTrials.gov ID
- NCT06683118
- Acronym / sponsor ID
- JUJI-2023-01-CIP-00
- Conditions
- Cerebral Atherosclerotic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2024 (actual)
- Primary completion
- 27 Jul 2025 (estimated)
- Study completion
- 27 Jul 2026 (estimated)
- First posted
- 12 Nov 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 purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
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: Rapamycin neurovascular Balloon Catheter |
| control group | Active comparator | Device: Conventional Balloon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- History of acute ischemic stroke within 2 weeks;
- Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
- Target vessels complete occlusion or with thrombus in target vessels;
- Target vessel with severe calcification or distortion that making interventional device is difficult to place;
- History of stenting in the target 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 |
|---|---|---|
| Rapamycin neurovascular Balloon CatheterDrug-coated balloon for the symptomatic cerebral atherosclerotic stenosis | Device | experimental group |
| Conventional BalloonConventional Balloon for the symptomatic cerebral atherosclerotic stenosis | Device | control group |
Primary outcome
Target lesion restenosis rate at 6 month postoperative
Time frame: 180±30days
The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method.
7 secondary outcomes
Technical succeed rate
Time frame: Intraoperation
Target vascular-related stroke or death at 30 days postoperatively
Time frame: 30±7days
Any stroke or death at 30 days postoperatively
Time frame: 30±7days
Target vascular-related stroke or death at 6 month postoperatively
Time frame: 180±30days
Any stroke or death at 6 month postoperatively
Time frame: 180±30days
Target vascular-related stroke or death at 12 month postoperatively
Time frame: 360±60days
Any stroke or death at 12 month postoperatively
Time frame: 360±60days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapamycin neurovascular Balloon Catheter and Conventional Balloon in people with Cerebral Atherosclerotic Stenosis, run by MicroPort NeuroTech Co., Ltd. at 2 sites 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 0 inclusion and 17 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Target lesion restenosis rate at 6 month postoperative (time frame: 180±30days). 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 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.