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IVUS-guided DES Implantation in Coronary Calcification

RecruitingNAAges 18 Years - anyAllNanjing First Hospital, Nanjing Medical University
NCT05800002 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction \> 48 hours, or ST-segment elevation myocardial infarction \> 7 days; 2. De novo coronary lesion eligible for drug-eluting stent implantation; 3. Target lesion with severe calcification; Exclusion Criteria: 1. Age less than 18-year-old; 2. Comorbidity with a life expectancy \<12 months; 3. Intolerant of antithrombotic therapy; 4. Significant anemia, thrombocytopenia, or leucopenia; 5. History of major hemorrhage (intracranial, gastrointestinal, and so on); 6. Chronic total occlusion lesion not recanalized; 7. Scheduled major surgery in the next 12 months; 8. Left ventricular ejection fraction \< 25%; 9. Uremia dependent on dialysis treatment; 10. Previous drug-eluting stent implantation in target vessel;
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What it tests

  • Intravascular ultrasound
  • Angiography
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Where

1 site
Nanjing First Hospital
Nanjing, 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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