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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • super high-pressure balloon

    Device

    preparation strategy for calcified lesions after unsatisfactory dilation

  • intravascular lithotripsy (IVL)

    Device

    preparation strategy for calcified lesions after unsatisfactory dilation

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Super high-pressure balloonExperimental treatment 1 intervention
Group B: Intravascular lithotripsy (IVL)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)).

Time frame
Intraprocedural

Secondary outcomes

1

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\[TVR\].

Time frame
30 days

Other outcomes

Sponsors and contacts

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