NCT07444346

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

Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions, a Prospective,Observational, Single-center Registry Study.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Calcification
• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	percutaneous coronary intervention	All enrolled patients underwent Intravascular Lithotripsy (IVL) and Percutaneous Coronary Intervention (PCI) under guideline-directed management.

Timeline

• Start date: 2026-02-10
• Primary completion: 2026-07-30
• Completion: 2027-01-30
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study
• FDA-regulated device study