Actively Recruiting
IVUS-guided DES Implantation in Coronary Calcification
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2024-11-15
864
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IVUS-guided DES Implantation in Coronary Calcification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction > 48 hours, or ST-segment elevation myocardial infarction > 7 days
- De novo coronary lesion eligible for drug-eluting stent implantation
- Target lesion with severe calcification
You will not qualify if you...
- Age less than 18 years old
- Comorbidity with a life expectancy less than 12 months
- Intolerant of antithrombotic therapy
- Significant anemia, thrombocytopenia, or leucopenia
- History of major hemorrhage (intracranial, gastrointestinal, and so on)
- Chronic total occlusion lesion not recanalized
- Scheduled major surgery in the next 12 months
- Left ventricular ejection fraction less than 25%
- Uremia dependent on dialysis treatment
- Previous drug-eluting stent implantation in target vessel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
J
Jun-Jie Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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