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
Launched by THE FIRST PEOPLE'S HOSPITAL OF CHANGZHOU · Apr 22, 2025
Trial Information
Current as of July 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age 18 to 80 years old;
- • 2. Symptomatic intracranial artery stenosis, the diameter of the target vessel measured by intracranial angiography was between 70 and 99% (WASID method);
- • 3. The stenosis vessels were in internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, vertebral artery (intracranial segment);
- • 4. The patient had at least one risk factor for intracranial atherosclerosis, including past or existing hypertension, hyperlipidemia, diabetes, smoking, etc.;
- • 5. mRS≤2 before enrollment;
- • 6. 1.25mm≤ target vessel diameter ≤4.5mm;
- • 7. Intracranial artery stenosis requiring interventional treatment was a single lesion;
- • 8. 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 Criteria:
- • 1. The target vessel is severely calcified and distorted, and the interventional instruments are difficult to be in place or recovered;
- • 2. Acute ischemic stroke occurred within 2 weeks before surgery;
- • 3. Cerebral hemorrhage occurred 3 months before surgery;
- • 4. The target lesion has been treated with interventional therapy before;
- • 5. Intracranial artery stenosis caused by non-atherosclerotic lesions;
- • 6. Intracranial aneurysm or intracranial arteriovenous malformation with an unpredictable high risk or risk of bleeding;
- • 7. Risk factors that may contribute to the risk of cardiogenic embolism (such as left ventricular thrombosis, myocardial infarction within 1 month);
- • 8. History of gastrointestinal bleeding within 6 months;
- • 9. Coagulation dysfunction or obvious bleeding tendency (such as INR \> 1.5);
- • 10. Known allergy to contrast agents, anticoagulants, anesthesia and other drugs, red light;
- • 11. Platelet count (PLT\<90×109/L);
- • 12. 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.
About The First People's Hospital Of Changzhou
The First People's Hospital of Changzhou is a leading healthcare institution dedicated to advancing medical research and enhancing patient care through innovative clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its state-of-the-art facilities and a multidisciplinary team of experienced healthcare professionals to conduct rigorous research across various therapeutic areas. Committed to ethical standards and patient safety, the First People's Hospital of Changzhou fosters collaboration with academic institutions and industry partners to drive medical breakthroughs and improve therapeutic outcomes for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Changzhou, Jiangsu, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported