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 | Enrolling By Invitation

• 1 other identifier: (2024) H. 002 (Ss. 01)
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company

Conditions

Prospective, Multicenter, Randomized, Controlled, and Superior Efficiency

Keywords

Intracranial Laser Balloon Dilation Catheter

Outcome Measures

Primary Outcomes (1)

• Immediate residual stenosis after surgery

  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%.

  Time：15 minutes after dilatation of the test or control apparatus.

Secondary Outcomes (5)

• Restenosis rate of target lesion after 6 months operation

  Time：6 months±30 days after operation

• The success rate of operation

  Time：15 minutes after dilatation of the test or control apparatus.

• Apparatus success rate

  Time：intraoperative

• Changes in NIHSS score within 7 days after surgery or before discharge

  7 days after surgery or before discharge

• Changes in mRS at 6 months after surgery

  6 months after operation

Study Arms (2)

Intracranial Laser Balloon Dilation Catheter and Laser Generator

EXPERIMENTAL

Experimental group：Name of Medical Apparatus ：Intracranial Laser Balloon Dilation Catheter and Laser Generator Manufacturer：Hangzhou Juzheng Medical Technology limited company

Device: Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.

Boston Scientific Corporation

ACTIVE COMPARATOR

Control group：Name of Medical Apparatus：Gateway PTA Balloon Catheter） Registrant：Boston Scientific Corporation Registration certificate number： CFDA(I) 20193032148

Device: Boston Scientific Corporation

Interventions

Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply. DEVICE

Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.

Intracranial Laser Balloon Dilation Catheter and Laser Generator

Boston Scientific Corporation DEVICE

Balloon dilation treatment for intracranial arterial stenosis in order to improve intracranial blood supply.

Boston Scientific Corporation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• mm≤ 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

Study Sites (1)

The First People's Hospital of Changzhou.

Changzhou, Jiangsu, The First People's Hospital of, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: April 11, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)