Prospective, Multicenter, Randomized, Controlled, and Superior EfficiencyLaser balloonNCT06950242
Clinical Trial of Safety and Efficacy of Intracranial Laser Balloon Dilation Catheter in Patients With Symptomatic Intracranial Atherosclerotic Stenosis: A Prospective, Multi-center, Randomized Comparison
A study testing Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. and Boston Scientific Corporation in people with Prospective, Multicenter, Randomized, Controlled, and Superior Efficiency, run by The First People's Hospital of Changzhou at 1 site in China.
Trial summary
Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prospective, Multicenter, Randomized, Controlled, and Superior Efficiency
- What is being tested?
- Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. and Boston Scientific Corporation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2024to 31 Dec 2026
- 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
- Age 18 to 80 years old;
- Symptomatic intracranial artery stenosis, the diameter of the target vessel measured by intracranial angiography was between 70 and 99% (WASID method);
- The stenosis vessels were in internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, vertebral artery (intracranial segment);
- The patient had at least one risk factor for intracranial atherosclerosis, including past or existing hypertension, hyperlipidemia, diabetes, smoking, etc.;
- mRS≤2 before enrollment;
- 1.25mm≤ target vessel diameter ≤4.5mm;
- Intracranial artery stenosis requiring interventional treatment was a single lesion;
- Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and can accept follow-up.
Who cannot join
- The target vessel is severely calcified and distorted, and the interventional instruments are difficult to be in place or recovered;
- Acute ischemic stroke occurred within 2 weeks before surgery;
- Cerebral hemorrhage occurred 3 months before surgery;
- The target lesion has been treated with interventional therapy before;
- Intracranial artery stenosis caused by non-atherosclerotic lesions;
- Intracranial aneurysm or intracranial arteriovenous malformation with an unpredictable high risk or risk of bleeding;
Show all 13Show fewer
- Risk factors that may contribute to the risk of cardiogenic embolism (such as left ventricular thrombosis, myocardial infarction within 1 month);
- History of gastrointestinal bleeding within 6 months;
- Coagulation dysfunction or obvious bleeding tendency (such as INR > 1.5);
- Known allergy to contrast agents, anticoagulants, anesthesia and other drugs, red light;
- Platelet count (PLT<90×109/L);
- Hemoglobin <100g/L; Uncontrolled severe hypertension (persistent: systolic >180mmHg or diastolic >110mmHg);
- Creatinine >3mg/dL, i.e. >265μmol/L; (15) Serious dysfunction of important organs such as heart, liver and kidney; (16) Those who are participating in clinical trials of other drugs or devices that do not meet the primary endpoint; (17) Women who are pregnant or breastfeeding, or who plan to pregnant within one year; (18) Life expectancy is less than 1 year; (19) The researcher determined that there were other circumstances that were not suitable for inclusion.
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 First People's Hospital of Changzhou.
Changzhou, Jiangsu, The First People's Hospital of
About this study
Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company
Read the detailed description
This trial is a prospective, multicenter, randomized controlled, high-efficacy clinical trial with a total of 134 participants. Among them, the sample size of randomized controlled trial calculated according to statistics was 128 cases. Patients who require balloon diameter 1.25mm/1.75mm/4.50mm will be assigned to single observation group and treated with intracranial laser balloon dilator catheter combined with laser generator, totaling 6 cases. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to use the intracranial laser balloon dilation catheter produced by Hangzhou Juzheng Medical Technology limited company in combination with a laser generator or the PTA balloon dilation catheter produced by Boston Scientific Company in the control group for the dilation of intracranial arterial stenosis, to verify the effectiveness of the experimental medical device. A clinical summary report will be issued for product registration application after 1-month postoperative follow-up, and a 6-month postoperative follow-up will be conducted to evaluate the medium and long-term efficacy.
The visit nodes for this trial are as follows: screen（Within 15 days before surgery）、 intraoperative、Within 7 days after surgery or before discharge (whichever comes first)、30 days ±7 days after surgery、6 months±30 days after surgery.
This study take immediate postoperative residual stenosis as the primary endpoint to verify the safety and effectiveness of intracranial laser balloon dilator catheter combined with laser generator produced by Hangzhou Juzheng Medical Technology limited company in the treatment of symptomatic intracranial atherosclerotic stenosis patients. The secondary endpoints are the restenosis rate of target lesion, the success rate of surgery, the success rate of instrument, the change of NIHSS score within 7 days after surgery or before discharge, and the change of mRS Score at 6 months after surgery. The incidence of intraoperative device defects, ischemic stroke, hemorrhagic stroke event, mortality, serious adverse events, and adverse events at 30 days and 6 months after surgery were used as safety endpoints to verify the safety and efficacy of the experimental devices.
- Being tested
- Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply., Boston Scientific Corporation
- Keywords
- Intracranial Laser Balloon Dilation Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.Device
Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.
Boston Scientific CorporationDevice
Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Laser Balloon Dilation Catheter and Laser Generator | Experimental | Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company Receives: Device: Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. |
| Boston Scientific Corporation | Active comparator | Control group：Name of Medical Apparatus：Gateway PTA Balloon Catheter） Registrant：Boston Scientific Corporation Registration certificate number： CFDA(I) 20193032148 Receives: Device: Boston Scientific Corporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate residual stenosis after surgery
Definition：Stenosis of target lesion lumen diameter (%) after test or control instrument dilation (15 minutes).
Formula： Stenosis of target lesion lumen diameter（%）=（1-Stenosis of target lesion lumen diameter (%) after test or control instrument dilation (15 minutes)）*100%.
Measured: Time：15 minutes after dilatation of the test or control apparatus.
Secondary outcomes (5)
Restenosis rate of target lesion after 6 months operation
Definition：DSA examination at 6 months after operation revealed the degree of lumen diameter stenosis of the target lesion>50% and absolute lumen loss>20% of target lesions.
Formula：degree of diameter stricture（%）=（1-Minimum lumen diameter of target lesion 6 months after surgery/reference vessel diameter of target lesion 6 months after surgery）*100%.
Measured: Time：6 months±30 days after operation
The success rate of operation
Definition: The proportion of patients with final target lesions with luminal diameter stenosis < 50% and mTICI grade 2b or 3, allowing for the use of additional therapies.
Measured: Time：15 minutes after dilatation of the test or control apparatus.
Apparatus success rate
Definition：The balloon dilatation catheter was successfully delivered in place, the balloon was successfully withdrawn after successful dilatation, the balloon was not ruptured or broken, and there was no equipment failure. The proportion of successful instruments will be calculated.
Measured: Time：intraoperative
Changes in NIHSS score within 7 days after surgery or before discharge
The NIHSS score was used to evaluate the functional recovery of the subjects within 7 days after surgery or before discharge.
Formula：Changes in NIHSS score = NIHSS score within 7 days after surgery or before discharge-baseline NIHSS score。
Measured: 7 days after surgery or before discharge
Changes in mRS at 6 months after surgery
mRS Score was used to evaluate the functional recovery of the subjects at 6 months after operation.
Formula：Changes in mRS = mRS at 6 months after surgery-baseline mRS score.
Measured: 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start11 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective, Multicenter, Randomized, Controlled, and Superior EfficiencyStudies 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950242
- Sponsor's protocol ID
- (2024) H. 002 (Ss. 01)
- Acronym
- Laser balloon
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Safety and Efficacy of Intracranial Laser Balloon Dilation Catheter in Patients With Symptomatic Intracranial Atherosclerotic Stenosis: A Prospective, Multi-center, Randomized Comparison
- ClinicalTrials.gov ID
- NCT06950242
- Acronym / sponsor ID
- Laser balloon / (2024) H. 002 (Ss. 01)
- Keywords
- Intracranial Laser Balloon Dilation Catheter
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Apr 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.
Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company
Detailed description
This trial is a prospective, multicenter, randomized controlled, high-efficacy clinical trial with a total of 134 participants. Among them, the sample size of randomized controlled trial calculated according to statistics was 128 cases. Patients who require balloon diameter 1.25mm/1.75mm/4.50mm will be assigned to single observation group and treated with intracranial laser balloon dilator catheter combined with laser generator, totaling 6 cases. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to use the intracranial laser balloon dilation catheter produced by Hangzhou Juzheng Medical Technology limited company in combination with a laser generator or the PTA balloon dilation catheter produced by Boston Scientific Company in the control group for the dilation of intracranial arterial stenosis, to verify the effectiveness of the experimental medical device. A clinical summary report will be issued for product registration application after 1-month postoperative follow-up, and a 6-month postoperative follow-up will be conducted to evaluate the medium and long-term efficacy.
The visit nodes for this trial are as follows: screen（Within 15 days before surgery）、 intraoperative、Within 7 days after surgery or before discharge (whichever comes first)、30 days ±7 days after surgery、6 months±30 days after surgery.
This study take immediate postoperative residual stenosis as the primary endpoint to verify the safety and effectiveness of intracranial laser balloon dilator catheter combined with laser generator produced by Hangzhou Juzheng Medical Technology limited company in the treatment of symptomatic intracranial atherosclerotic stenosis patients. The secondary endpoints are the restenosis rate of target lesion, the success rate of surgery, the success rate of instrument, the change of NIHSS score within 7 days after surgery or before discharge, and the change of mRS Score at 6 months after surgery. The incidence of intraoperative device defects, ischemic stroke, hemorrhagic stroke event, mortality, serious adverse events, and adverse events at 30 days and 6 months after surgery were used as safety endpoints to verify the safety and efficacy of the experimental devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracranial Laser Balloon Dilation Catheter and Laser Generator | Experimental | Device: Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company |
| Boston Scientific Corporation | Active comparator | Device: Boston Scientific CorporationControl group：Name of Medical Apparatus：Gateway PTA Balloon Catheter） Registrant：Boston Scientific Corporation Registration certificate number： CFDA(I) 20193032148 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 80 years old;
- Symptomatic intracranial artery stenosis, the diameter of the target vessel measured by intracranial angiography was between 70 and 99% (WASID method);
- The stenosis vessels were in internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, vertebral artery (intracranial segment);
- The patient had at least one risk factor for intracranial atherosclerosis, including past or existing hypertension, hyperlipidemia, diabetes, smoking, etc.;
- mRS≤2 before enrollment;
Key exclusion criteria (13 listed)
- The target vessel is severely calcified and distorted, and the interventional instruments are difficult to be in place or recovered;
- Acute ischemic stroke occurred within 2 weeks before surgery;
- Cerebral hemorrhage occurred 3 months before surgery;
- The target lesion has been treated with interventional therapy before;
- Intracranial artery stenosis caused by non-atherosclerotic lesions;
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 dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. | Device | Intracranial Laser Balloon Dilation Catheter and Laser Generator |
| Boston Scientific CorporationBalloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. | Device | Boston Scientific Corporation |
Primary outcome
Immediate residual stenosis after surgery
Time frame: Time：15 minutes after dilatation of the test or control apparatus.
Definition：Stenosis of target lesion lumen diameter (%) after test or control instrument dilation (15 minutes). Formula： Stenosis of target lesion lumen diameter（%）=（1-Stenosis of target lesion lumen diameter (%) after test or control instrument dilation (15 minutes)）*100%.
5 secondary outcomes
Restenosis rate of target lesion after 6 months operation
Time frame: Time：6 months±30 days after operation
The success rate of operation
Time frame: Time：15 minutes after dilatation of the test or control apparatus.
Apparatus success rate
Time frame: Time：intraoperative
Changes in NIHSS score within 7 days after surgery or before discharge
Time frame: 7 days after surgery or before discharge
Changes in mRS at 6 months after surgery
Time frame: 6 months after operation
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 30 Apr 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. and Boston Scientific Corporation in people with Prospective, Multicenter, Randomized, Controlled, and Superior Efficiency, run by The First People's Hospital of Changzhou 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 8 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 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?
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?
Immediate residual stenosis after surgery (time frame: Time：15 minutes after dilatation of the test or control apparatus.). 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 30 Apr 2025.