Clinical Trial of Safety and Efficacy of Intracranial Laser Balloon Dilation Catheter in Patients… (NCT06950242) | Clinical Trial Compass
By InvitationNot Applicable
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
China128 participantsStarted 2024-04-11
Plain-language summary
Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
Immediate residual stenosis after surgery
Timeframe: Time：15 minutes after dilatation of the test or control apparatus.