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Enrolling by invitation Not 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

NCT06950242 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-04-11
Last updated
2025-04-30

Condition(s) studied

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)

FacilityCityRegionStatus
The First People's Hospital of Changzhou. Changzhou Jiangsu
Official registry record

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.

View NCT06950242 on ClinicalTrials.gov ↗ ← All trials in China