Using IVUS to guide stent placement in patients with coronary calcification
Official title: Intravascular Ultrasound Versus Angiography Guided Drug-eluting Stent Implantation for Patients With Coronary Severe Calcification: a Prospective, Multicenter, Randomized Controlled Trial
Run by Nanjing First Hospital, Nanjing Medical University · NCT05800002 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 864 (estimated) |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | April 7, 2023 |
| Main results expected | March 30, 2026 |
| Study ends | March 30, 2033 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT05800002 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with significant comorbidities, recent major hemorrhage, or those who are intolerant to antithrombotic therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown the benefits of IVUS guidance in various coronary interventions, but its specific application in severe calcification remains largely untested.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: jameszll@163.com
- Phone: 025-52271350
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.