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

N/ANot Yet RecruitingNCT07444346

The First Affiliated Hospital with Nanjing Medical University200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Coronary Artery Calcification Coronary Artery Disease

Interventions

percutaneous coronary interventionPROCEDURE

All enrolled patients underwent Intravascular Lithotripsy (IVL) and Percutaneous Coronary Intervention (PCI) under guideline-directed management.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.