Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques (NCT06416813) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Preventive Intervention Value of DCB in Vulnerable Coronary Atherosclerotic Plaques
China140 participantsStarted 2025-06-06
Plain-language summary
The PASSIVATE-CAP study is an investigator-initiated, prospective, randomized, multicenter, open-label superiority trial focusing on acute coronary syndrome (ACS) patients with nonflow-limiting vulnerable plaques in nonculprit vessels. In this study, eligible patients were randomized at a 1:1 ratio into two groups: patients who received guideline-directed medical therapy (GDMT) and patients who received GDMT combined with a drug-coated balloon (DCB). In this study, the use of PCSK9 inhibitors was limited to inclisiran. The primary endpoint was the minimal lumen area of the target lesion 1 year after randomization. The secondary endpoints encompass a range of factors, including the proportion of patients with vulnerable plaques in the target vessel, fibrous cap thickness, lipid core arc of the target lesion, minimal lumen area of the target vessel, and extent of LDL-C reduction in patients treated with inclisiran.
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 Diagnosis of ACS with the intention to undergo ICA There exists a nonculprit lesion characterized by a single diameter stenosis greater than 50% in the major coronary artery segments (with diameters ranging from 2.75 to 4 mm).
QFR value \> 0.8 The OCT examination suggests vulnerable plaques with a fibrous cap thickness of \< 65 µm, along with at least two of the other three OCT criteria Minimum lumen area \<3.5 mm² Lipid core angle \>180° Presence of macrophages lesion length ≤30 mm Provide informed consent Life expectancy greater than 1 year
Exclusion Criteria:
Patients with three or more target lesions or with two target lesions in the same coronary artery left main stem lesions Ostial lesions Thrombotic lesions Severe calcification or angulated lesions True bifurcation lesions requiring stent implantation Advanced heart failure (NYHA III-IV) Ischemic stroke in the past 6 months or any history of cerebral hemorrhage at any time Severe valve disease or valve disease that may require surgical or percutaneous valve replacement Coronary artery anatomy obstructs the complete imaging of the segment of interest (including at least 5 mm beyond the narrow ends).
Diffuse coronary artery disease or the presence of ≥1 untreated nonculprit lesion (nonculprit blood flow-restricting lesion planned for staged PCI).
History of myocardial infarction, CABG, or PCI Coronary artery anatomy not suitable for PCI The potential comorbidity that may impact th…
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.