CompletedNot Applicable

Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk

China60 participantsStarted 2019-07-30

Plain-language summary

This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).

Who can participate

Age range

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.

Inclusion Criteria: * De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test; * Coronary artery disease (CAD) patients with high risk of bleeding Exclusion Criteria: * Previous coronary artery bypass graft (CABG) patients * Stent implantation in the target vessel * Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 * Acute ST segment elevation myocardial infarction (STEMI) within 48 hours * Contraindications to contrast media, antiplatelet therapy, or paclitaxel * Cardiac shock * Pregnancy * Expected life less than 12 months

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

The absolute change in minimal lumen area (MLA)

Timeframe: 6 months

Trial details

NCT IDNCT03817801

SponsorNanjing First Hospital, Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-30

View on ClinicalTrials.gov More Coronary Artery Disease trials