Actively Recruiting
DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR
Led by Shanghai Zhongshan Hospital · Updated on 2026-03-02
656
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
S
Shanghai Zhongshan Hospital
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 18 years
- Moderate to severe calcified lesions assessed by coronary angiography
- Presence of in situ coronary artery calcification
- Target lesion with indications for coronary intervention
- Target lesion vessel diameter 3 2.25 mm and 4.0 mm
- Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA)
- Quantitative flow ratio (QFR) greater than 0.8 after calcification modification
You will not qualify if you...
- 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
- Patients with other medical conditions and a life expectancy of less than 1 year
- Patients scheduled for surgery within 6 months post-procedure that interferes with antiplatelet therapy
- Patients who cannot tolerate dual antiplatelet therapy
- Patients unable to adhere to the protocol-required follow-up or deemed risky by the investigator
- Patients unable to provide written informed consent or follow the trial protocol
- Patients currently participating in another clinical trial for coronary interventional devices
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China, 200032
Actively Recruiting
Research Team
J
Jianying Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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