Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

Eligibility criteria

Qualifiers

Age > 18 years and < 80 years

Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).

Have an indication for drug-eluting stent (DES) implantation

Denovo coronary artery calcified lesions

Disqualifiers

Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure

Presented as severe contrast agent allergy

Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy

Presented as active phase of autoimmune disease

Trial design

Treatments tested in this trial

  • super high-pressure balloon
  • intravascular lithotripsy (IVL)

Treatment groups

78 Participants
are divided into 2 treatment groups