Not Yet RecruitingNot Applicable

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

China200 participantsStarted 2026-02-10

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and moderate to severe calcification;
✓. Reference vessel diameter ≥ 2.5 mm;
✓. Signed informed consent form.

Exclusion criteria

✕. Patients with comorbid conditions such as malignant tumors and an expected lifespan of less than 1 year;
✕. Patients with hemodynamic instability;
✕. Patients classified as New York Heart Association (NYHA) functional class IV;
✕. Any other conditions deemed by the investigator as unsuitable for enrollment.

What they're measuring

MACE: All-Cause Death, Recurrent Myocardial Infarction, Unplanned Target Vessel Revascularization, Acute Stent Thrombosis.

Timeframe: Periprocedurally and 6 months after PCI

Trial details

NCT IDNCT07444346

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-30

Contact for this trial

Chunjian Li, PHD

13701465229 lijay@njmu.edu.cn

View on ClinicalTrials.gov More Coronary Artery Calcification trials