IVUS-guided DES Implantation in Coronary Calcification

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special imaging technique called intravascular ultrasound (IVUS) to guide the placement of drug-eluting stents (DES) in patients with severe calcification in their coronary arteries. Coronary artery disease can lead to blockages in the heart's blood vessels, and these calcified lesions can make treatment more challenging. The goal of the trial is to determine if using IVUS to guide the stent placement can improve outcomes for patients with these difficult lesions, building on previous research that showed benefits of IVUS in other cases.

To participate in this trial, potential candidates should be between the ages of 65 and 74 and have conditions like stable or unstable angina (chest pain) or a recent heart attack. They must have a new blockage in a coronary artery that is severely calcified and needs a stent. However, individuals under 18, those with certain health issues that could affect their life expectancy, or those who have had previous stents in the same vessel are not eligible. Participants can expect close monitoring and care as they undergo this innovative treatment approach, contributing to research that could improve future care for patients with similar heart issues.

Gender

ALL

Eligibility criteria

• 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;