Status:
ENROLLING_BY_INVITATION
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
Lead Sponsor:
The First People's Hospital of Changzhou
Conditions:
Prospective, Multicenter, Randomized, Controlled, and Superior Efficiency
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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);
- (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.
Key Trial Info
Start Date :
April 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06950242
Start Date
April 11 2024
End Date
December 31 2026
Last Update
April 30 2025
Active Locations (1)
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1
The First People's Hospital of Changzhou.
Changzhou, Jiangsu, China, The First People's Hospital of