Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions.

Nanjing Medical University

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Coronary Artery Calcification

Treatments: Procedure: percutaneous coronary intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07444346

033

Details and patient eligibility

About

This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

IVL group

Description:

Patients in the IVL group all received intravascular lithotripsy treatment.

Treatment:

Procedure: percutaneous coronary intervention