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

February 26, 2026 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary Artery disease and moderate to severe coronary artery calcification scheduled for PCI treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVL group
Patients in the IVL group all received intravascular lithotripsy treatment.
Procedure: percutaneous coronary intervention
All enrolled patients underwent Intravascular Lithotripsy (IVL) and Percutaneous Coronary Intervention (PCI) under guideline-directed management.
Other Names:
  • intravascular lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MACE: All-Cause Death, Recurrent Myocardial Infarction, Unplanned Target Vessel Revascularization, Acute Stent Thrombosis.
Time Frame: Periprocedurally and 6 months after PCI
Periprocedurally and 6 months after PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
Residual stenosis rate after PCI.
Time Frame: Immediately after the PCI
Immediately after the PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on percutaneous coronary intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe