A Randomized Study of Cutting Balloon Catheter for CAD (NCT07140822) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Study of Cutting Balloon Catheter for CAD
China166 participantsStarted 2023-04-26
Plain-language summary
This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be randomly assigned to the test group and the control group according to a ratio of 1:1 for balloon dilatation for the treatment of coronary artery disease.
Who can participate
Age range
18 Years – 80 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.
Exclusion criteria
. Pregnant or lactating women or women who are planning pregnancy;
. Subjects with myocardial infarction occurred within one week; the myocardial enzyme TNI or TNT has not returned to normal although myocardial infarction has occurred for more than one week;
. Subjects who are considered by the investigator through angiography that the cutting balloon cannot pass through even dilatation with a small one and need a rotational atherectomy;
. Non-target vessels, which can be treated simultaneously with the target blood vessel, have not been treated well in advance, or the total number of lesions on the non-target blood vessel is \> 3;
. NYHA Class IV patients;
. Patients with severe renal failure (creatinine \> 443 μmol/L) or ongoing hemodialysis therapy;
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
1
Acute gain
Timeframe: Before and after balloon dilation
Trial details
NCT IDNCT07140822
SponsorShanghai Shenqi Medical Technology Co., Ltd