About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Moderate to severe calcified lesions assessed by coronary angiography
In situ coronary artery calcification
Target lesion with indications for coronary intervention
Disqualifiers
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.
Trial design
Treatments tested in this trial
- rotational atherectomy (RA)
- excimer laser coronary angioplasty (ELCA)
- Intravascular Lithotripsy (IVL)
Treatment groups
Sponsors and collaborators
Shanghai Zhongshan Hospital
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Tenth People's Hospital affiliated to Tongji University
Collaborator