Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
Nanjing First Hospital, Nanjing Medical University
78 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria9
- 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
- Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \< 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
- Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
- Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
- Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \< 30% under maximal inflation pressure.
- Provision of written informed consent
Exclusion Criteria8
- 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
- Calcified nodules or eccentric calcification lesions
- Failure to reach the target lesion with guidewires or catheters
- Complex coronary bifurcation lesions
- Target vessel thrombosis or aneurysm within 10 mm of the target lesion
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Interventions
preparation strategy for calcified lesions after unsatisfactory dilation
preparation strategy for calcified lesions after unsatisfactory dilation
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07093788