Not Yet RecruitingNot Applicable

Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

204 participantsStarted 2023-11

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

6-month target lesion restenosis rate

Timeframe: 6-month

Trial details

NCT IDNCT06140550

SponsorBochang

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12

View on ClinicalTrials.gov More Intracranial Atherosclerotic Stenosis trials