Not Yet RecruitingNot Applicable

Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter

400 participantsStarted 2024-05-10

Plain-language summary

The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world. The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.

Who can participate

Age range

18 Years

Sex

ALL

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: * Age ≥ 18 years; * Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm; * Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol. Exclusion Criteria: * Pregnant or lactating females; * Patients with cardiogenic shock; * Patients with severe congestive heart failure or severe heart failure with NYHA class IV; * Patients with severe valvular heart disease; * Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult; * Patients who are considered unsuitable for inclusion by the investigator for other reasons. * Those who are known to be allergic to melcrolimus and contrast media.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Target lesion failure rate (TLF)

Timeframe: 12 months after surgery

Trial details

NCT IDNCT06385067

SponsorJW Medical Systems Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-30

Contact for this trial

Yuanchun Sun

13683382463 sunyuanchun@bluesail.cn

View on ClinicalTrials.gov More Coronary Artery Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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