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

NCT ID: NCT04949880

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2023-05-31

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.

Conditions

Intracranial Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Neurovascular Drug-Eluting Balloon Dilatation Catheter

Group Type: EXPERIMENTAL

Neurovascular Drug-Eluting Balloon Dilatation Catheter

Intervention Type: DEVICE

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.

Interventions

Neurovascular Drug-Eluting Balloon Dilatation Catheter

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.

Intervention Type: DEVICE

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Zylox Medical Device Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianmin Liu

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Liqun Jiao

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

The First Affiliated Hospital of USTC

Hefei, Anhui, China

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Cangzhou Central hospital

Cangzhou, Hebei, China

Wuhan Hospital of Traditional Chinese and Western Medicine

Wuhan, Hubei, China

General Hospital of Northen Theater Command

Shenyang, Liaoning, China

Linyi People's Hospital

Linyi, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, , China

Xuanwu Hospital Capital Medical University

Beijing, , China

Changhai Hospital of Shanghai

Shanghai, , China

Countries

China

Other Identifiers

ZYLOX34202105

Identifier Type: -

Identifier Source: org_study_id