Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions (NCT05552911) | Clinical Trial Compass
UnknownNot Applicable
Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions
China400 participantsStarted 2022-01-01
Plain-language summary
This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.
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
. Patients aged ≥18 years with coronary heart disease;
. If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
. Residual lumen diameter stenosis ≤30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;
. Target lesions were treated with DCB for the first time.
Exclusion criteria
. Intraoperative implantation of salvage stent in DCB;
. Acute myocardial infarction occurred within 1 week after DCB operation;
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
LLL of 12±3 months after surgery
Timeframe: 12±3 months after surgery
Trial details
NCT IDNCT05552911
SponsorThe First Affiliated Hospital with Nanjing Medical University