DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR (NCT07277114) | Clinical Trial Compass
RecruitingNot Applicable
DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR
China656 participantsStarted 2026-02-01
Plain-language summary
The goal of this clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). The main questions it aims to answer are:
1. Researchers will compare to see if DCB is non-inferior to DES when evaluated by major cardiovascular adverse events (MACE) one year after percutaneous coronary intervention (PCI).
2. Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions.
3. Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI.
Participants with severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound (IVUS) will receive calcium modification through rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), or intravascular lithotripsy (IVL). Then, QFR will be measured based on angiographic image. QFR \>0.8 will be defined as optimal calcium modification and patients will be randomized 1:1 to DCB or DES treated groups. Telephone follow-ups will be conducted at 1 month, 6 months after PCI and .angiophraphy follow-up will be performed at 12 months after PCI.
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
* Moderate to severe calcified lesions assessed by coronary angiography
* In situ coronary artery calcification
* Target lesion with indications for coronary intervention
* Target lesion vessel diameter ≥ 2.25 mm and ≤ 4.0 mm
* Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA).
* QFR \> 0.8 after calcification modification
Exclusion Criteria:
* Patients with ST-segment elevation myocardial infarction:
* Patients with renal failure requiring dialysis or currently undergoing dialysis.
* Patients whose coronary angiography quality is unsuitable for QFR analysis.
* Patients with in-stent restenosis.
⑤ Patients with other medical conditions and a life expectancy of \<1 year.
⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy.
⑦ Patients who cannot tolerate dual antiplatelet therapy.
⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator.
⑨ Patients who cannot provide written informed consent or cannot follow the trial protocol.
⑩ Patients currently participating in another clinical trial for coronary interventional devices.
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
Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction.