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
Prospective, Multicenter, Randomized, Controlled, and Superior Efficiency
Investigational drug(s) / intervention(s)
Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.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.
Boston Scientific Corporation: Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.
Study summary
Experimental group:Name of Medical Apparatus :Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer:Hangzhou Juzheng Medical Technology limited company
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Immediate residual stenosis after surgery — 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%.
Trial sites (1)
Facility
City
Region
Status
The First People's Hospital of Changzhou.
Changzhou
Jiangsu
More The First People's Hospital of Changzhou trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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