Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

Bochang

Status

Not yet enrolling

Conditions

Intracranial Atherosclerotic Stenosis

Treatments

Device: balloon dilated

Device: Drug balloon dilated

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06140550

TP-NS-036

Details and patient eligibility

About

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.

Enrollment

204 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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;