A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic Intracranial Atherosclerotic Stenosis

Study Overview
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Brief Summary
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This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.

Detailed Description
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This is a prospective multicentre single-arm trial conducted by 11 centers in mainland China. Approximately 132 subjects with symptomatic intracranial atherosclerotic stenosis receive endovascular treatment using the neurovascular drug-eluting balloon dilatation catheter designed by Zylox.

Official Title
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The Efficacy and Safety Study for Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis Using Neurovascular Drug-Eluting Balloon Dilatation Catheter: A Prospective Multicentre Single-arm Trial

Conditions
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Intracranial Atherosclerosis

Intervention / Treatment
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* Device: Neurovascular Drug-Eluting Balloon Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 80 years, any gender; Subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography; The target stenotic artery locates in Internal Carotid Artery (intracranial segment), Middle Cerebral Artery (M1, M2), Basilar Artery, Vertebral Artery (intracranial segment); Intracranial artery stenosis requiring interventional treatment is a single lesion; Subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age>45; modified Rankin Scale(mRS) score≤2 before enrollment; Subject or guardian is able to understand the purpose of study, agree to provide follow-up data and has provided written informed consent. Exclusion Criteria: History of acute ischemic stroke within 2 weeks; History of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months; Hypertension uncontrolled by medicine (Systolic pressure≥180 mmHg or diastolic pressure≥110 mmHg continuously); Combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation; The length of intracranial artery stenosis >10mm and extremely angulated >90°, which indicated by angiography; History of stent intervention within the target lesion; Allergic to heparin, sirolimus (i.e. rapamycin), contrast agents, aspirin, clopidogrel, anesthetics; History of gastrointestinal hemorrhage within 6 months before signing the informed consent form, which is unable to receive antiplatelet therapy; Platelet (PLT)<90*10^9/L; Creatinine>250 umol/L; International Normalized Ratio (INR)>1.5; Female subject who is pregnant or breast-feeding, or who has a pregnancy plan within 12 months; Expected life <12 months; Unable to cooperate with or tolerate the interventional surgery; Subject who has participated in other drug or device clinical trials or hasn't reached the primary end point; Angiography indicates intracranial artery stenosis caused by arterial dissection, arteritis, and thrombosis; Angiography indicates the vascular path is tortuous, the experimental device is difficult to reach the target position or be retracted; Other circumstances judged by researchers that are not suitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Neurovascular Drug-Eluting Balloon Dilatation Catheter | Device: Neurovascular Drug-Eluting Balloon Dilatation Catheter<br>* The neurovascular drug-eluting balloon dilatation catheter consists of a tip, a drug-coated balloon, markers, a catheter and a catheter hub. The main component of the drug coating is sirolimus, and the coating is evenly distributed on the effective length surface of the balloon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate of the target lesion | Subjects receive Digital Subtraction Angiography (DSA) / Computed Tomography Angiography (CTA) examination in 180 days to analyze whether the degree of stenosis is greater than or equal to 50%, if so, the target lesion restenosis happens. | 180+60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average stenosis degree of the target lesion | Subjects receive DSA / CTA examination in 180 days. | 180+60 days | 
| Success rate of device | After receiving DSA examination, success rate of device is defined as experimental device-neurovascular drug-eluting balloon dilatation catheter advanced on position successfully, balloon retracted smoothly after expanded, without balloon rupture and balloon catheter break, etc. | Intraoperation | 
| Success rate of surgery | After receiving DSA examination, success rate of surgery is defined as the final residual stenosis degree of target lesion<50% and modified thrombolysis in cerebral infarction score (mTICI) 2b/3, whether or not other additional treatments are applied. | Intraoperation |