Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

November 17, 2023 updated by: Bochang

Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Biolimus-coated Intracranial Balloon Dilation Catheter Treatment of Patients With Symptomatic Intracranial Atherosclerotic Stenosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 80 years old;
  • Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70~99%(WASID method);

Exclusion Criteria:

  • Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;
  • Ischemic cerebral infarction occurred 3 weeks before surgery;
  • Cerebral hemorrhage 3 months before operation;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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
Experimental: Control group
Device: balloon dilated
Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6-month target lesion restenosis rate
Time Frame: 6-month
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bochang

Collaborators

First People's Hospital of Hangzhou
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Qingdao University
Xuanwu Hospital, Beijing
Jinan Central Hospital
Beijing Geriatric Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 20, 2023

Study Record Updates

Last Update Posted (Actual)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-NS-036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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