DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR

Recruiting now · Not applicable

Conditions studied: Coronary Calcification

In brief

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.

Key facts

Study ID: NCT07277114
Run by: Shanghai Zhongshan Hospital
People needed: 656
Starts: 2026-02-01
Expected to finish: 2030-12-31
Last updated by the study team: 2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Zhongshan Hospital, Fudan University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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