Coronary Artery Calcification, Coronary Artery Disease
Conditions
Keywords
intravascular lithotripsy, coronary artery calcification, percutaneous coronary intervention
Brief summary
This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.
Detailed description
Coronary artery calcification is caused by the deposition of calcium within the coronary arteries, leading to increased vascular stiffness and serving as an independent risk factor for adverse cardiovascular events in patients with coronary artery disease. During percutaneous coronary intervention (PCI) for severe coronary artery calcification, procedural challenges such as device delivery difficulties, inadequate balloon expansion, incomplete stent deployment, and even coronary artery perforation are frequently encountered. Therefore, the identification and pretreatment of calcified lesions are of paramount importance in PCI procedures. This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloons for treating coronary calcified lesions at our center. Using a consecutive enrollment approach, patients with moderate to severe coronary artery calcification will undergo IVL treatment under the guidance of optical coherence tomography (OCT) or intravascular ultrasound (IVUS). Clinical data, procedural parameters, and intracoronary imaging data will be collected to establish a clinical-intracoronary imaging database for patients with severe coronary artery calcification, including subgroups such as acute coronary syndrome (ACS), chronic coronary syndrome (CCS), and cases of incomplete stent expansion. The study will address the following objectives: Evaluate the efficacy and safety of IVL in treating severe coronary artery calcification. Analyze factors influencing residual stenosis immediately after PCI and develop a machine learning-based risk prediction model for moderate or greater residual stenosis (residual stenosis \> 30%). Compare the efficacy of different intracoronary imaging modalities (IVUS vs. OCT) in guiding IVL for the pretreatment of severe coronary calcified lesions. Investigate the application of IVL balloons in treating calcified nodules.
Interventions
PROCEDUREpercutaneous coronary intervention
All enrolled patients underwent Intravascular Lithotripsy (IVL) and Percutaneous Coronary Intervention (PCI) under guideline-directed management.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and moderate to severe calcification; 2. Reference vessel diameter ≥ 2.5 mm; 3. Signed informed consent form.
Exclusion criteria
1. Patients with comorbid conditions such as malignant tumors and an expected lifespan of less than 1 year; 2. Patients with hemodynamic instability; 3. Patients classified as New York Heart Association (NYHA) functional class IV; 4. Any other conditions deemed by the investigator as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE: All-Cause Death, Recurrent Myocardial Infarction, Unplanned Target Vessel Revascularization, Acute Stent Thrombosis. | Periprocedurally and 6 months after PCI |
Secondary
| Measure | Time frame |
|---|---|
| Residual stenosis rate after PCI. | Immediately after the PCI |
Countries
China
Contacts
CONTACTChunjian Li, PHD
CONTACTLei Xu, MD
Outcome results
None listed