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

NCT04949880 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2022-10-17

No results posted yet for this study

Summary

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

Conditions

  • Intracranial Atherosclerosis

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Zhejiang Zylox Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianmin Liu · Changhai Hospital

  • Liqun Jiao · Xuanwu Hospital, Beijing

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04949880 on ClinicalTrials.gov