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

RecruitingNAAges 18 Years - 80 YearsAllNanjing First Hospital, Nanjing Medical University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

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

3 sites
Lianyungang First People's Hospital
Lianyungang, China
Nanjing First Hospital
Nanjing, China
Yixing People's Hospital
Yixing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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