NCT06140550

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Nov 2023

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 20, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 14, 2023

Last Update Submit

November 17, 2023

Conditions

Intracranial Atherosclerotic Stenosis

Keywords

Intracranial balloonstenosis

Outcome Measures

Primary Outcomes (1)

  • 6-month target lesion restenosis rate

    6-month

Study Arms (2)

Experimental group

EXPERIMENTAL
Device: Drug balloon dilated

Control group

EXPERIMENTAL
Device: balloon dilated

Interventions

Drug balloon dilatedDEVICE

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 group
balloon dilatedDEVICE

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

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Ratio of control group to test group 1:1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 20, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

November 20, 2023

Record last verified: 2023-11