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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Eligibility criteria

Qualifiers

Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and moderate to severe calcification;

Reference vessel diameter ≥ 2.5 mm;

Signed informed consent form.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • percutaneous coronary intervention

Treatment groups

200 Participants
are divided into 1 treatment group