Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

N/ANot Yet RecruitingNCT06140550

Bochang204 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

204

Conditions

Intracranial Atherosclerotic Stenosis

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

balloon dilatedDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

6-month target lesion restenosis rate

Time frame: 6-month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.