An interventional study of Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. and Boston Scientific Corporation in Prospective, Multicenter, Randomized, Controlled, and Superior Efficiency, sponsored by The First People's Hospital of Changzhou. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by The First People's Hospital of Changzhou · Not applicable, Interventional, and Treatment
Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company
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.
Exclusion Criteria:
(14) 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.
Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company
Device: Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.
Control group：Name of Medical Apparatus：Gateway PTA Balloon Catheter） Registrant：Boston Scientific Corporation Registration certificate number： CFDA(I) 20193032148
Device: Boston Scientific Corporation
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.
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%.
Time frame: Time：15 minutes after dilatation of the test or control apparatus.
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%.
Time frame: 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.
Time frame: 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.
Time frame: 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。
Time frame: 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.
Time frame: 6 months after operation
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The First People's Hospital of Changzhou