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

Zhejiang Zylox Medical Device Co., Ltd.11 sites in 1 country132 target enrollmentNovember 2, 2021

ConditionsIntracranial Atherosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Atherosclerosis
Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Enrollment: 132
Locations: 11
Primary Endpoint: Restenosis rate of the target lesion
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

November 2, 2021

End Date

May 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Restenosis rate of the target lesion

Time Frame: 180+60 days

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.