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

Zhejiang Zylox Medical Device

Status

Active, not recruiting

Conditions

Intracranial Atherosclerosis

Treatments

Device: Neurovascular Drug-Eluting Balloon Dilatation Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT04949880

ZYLOX34202105

Details and patient eligibility

About

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

Full 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.

Enrollment

132 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.