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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • percutaneous coronary intervention

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: IVL group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Periprocedurally and 6 months after PCI

Secondary outcomes

1

Residual stenosis rate after PCI.

Time frame
Immediately after the PCI

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: