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Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

NCT06140550 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2023-11-20

No results posted yet for this study

Summary

This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.

Conditions

  • Intracranial Atherosclerotic Stenosis

Interventions

DEVICE

Drug balloon dilated

Through the expansion after the balloon is in place,Release drugs on the surface of the balloon and improve the blood perfusion of nerve vessels to treat stenosis

DEVICE

balloon dilated

Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • First People's Hospital of Hangzhou

    collaborator OTHER

  • Jinan Central Hospital

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Beijing Geriatric Hospital

    collaborator OTHER

  • Bochang

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-12-31
Completion
2026-12-31

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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 NCT06140550 on ClinicalTrials.gov