Using IVUS to guide stent placement in patients with coronary calcification

Intravascular Ultrasound Versus Angiography Guided Drug-eluting Stent Implantation for Patients With Coronary Severe Calcification: a Prospective, Multicenter, Randomized Controlled Trial

This study is testing if using ultrasound during stent placement can help people with severe coronary calcification have better outcomes than using traditional imaging methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 864 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05800002 on ClinicalTrials.gov

What this trial studies

This study investigates the use of intravascular ultrasound (IVUS) to guide the implantation of drug-eluting stents (DES) in patients with severe coronary calcification. It aims to determine whether IVUS guidance can improve clinical outcomes compared to traditional angiography guidance in this specific patient population. The study will include patients with various forms of coronary artery disease, particularly those with calcified lesions that are eligible for stent placement. The findings could provide valuable insights into the effectiveness of IVUS in enhancing procedural success and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults with stable or unstable angina, silent ischemia, or recent myocardial infarction who have severe calcified coronary lesions eligible for drug-eluting stent implantation.

Not a fit: Patients with significant comorbidities, recent major hemorrhage, or those who are intolerant to antithrombotic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved clinical outcomes for patients with severe coronary calcification undergoing stent implantation.

How similar studies have performed: Previous studies have shown the benefits of IVUS guidance in various coronary interventions, but its specific application in severe calcification remains largely untested.

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;

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Shao-Liang Chen, MD — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Jun-Jie Zhang, MD

Conditions: Coronary Artery Disease