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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
super high-pressure balloon
Devicepreparation strategy for calcified lesions after unsatisfactory dilation
intravascular lithotripsy (IVL)
Devicepreparation strategy for calcified lesions after unsatisfactory dilation
Treatment groups
Trial outcomes
Primary outcomes
stent expansion index
The stent expansion was associated with post-PCI clinical outcomes and the risk of stent failure.In this study, the primary endpoint was stent expansion index, which was defined as the final minimal luminal area (MLA) within the treated segment divided by the average reference vessel area assessed with intravascular imaging (optical coherence tomography(OCT)\&intravascular ultrasound(IVUS)).
Secondary outcomes
30-days major adverse cardiac event (MACE)
The secondary endpoint was defined as the occurrence of major adverse cardiac events within 30 days, which was defined as a composite of cardiac death, target vessel-related myocardial infarction \[TVMI\] and clinically driven target vessel revascularisation\[TVR\].
Sponsors and contacts
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