Plaque Modification and Drug Coated Balloons for Treatment of de Novo Calcific Coronary Lesions (NCT07515703) | Clinical Trial Compass
CompletedNot Applicable
Plaque Modification and Drug Coated Balloons for Treatment of de Novo Calcific Coronary Lesions
Italy134 participantsStarted 2019-03-01
Plain-language summary
The optimal management of severely calcified coronary artery disease remains challenging, particularly in the context of drug-coated balloon (DCB) angioplasty. This study aimed to evaluate the feasibility, safety, and mid-term clinical outcomes of a DCB-only strategy following coronary modification systems (CMS) in patients with heavily calcified de novo coronary atherosclerotic disease.
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:
* Inclusion criteria comprised patients aged ≥18 years with stable or unstable coronary artery disease (chronic coronary syndrome \[CCS\] or acute coronary syndrome \[ACS\]) eligible for percutaneous coronary intervention (PCI).
Exclusion Criteria:
* Angiographic exclusion criteria included in-stent restenosis (ISR), lesions treated with a hybrid approach (DCB plus drug-eluting stent \[DES\]), residual stenosis \>30%, or ≥ type C dissection after lesion preparation. Clinical exclusion criteria were hemodynamic instability and life expectancy \<1 year.
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
procedural success, defined as <30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial im)