IVUS-guided DES Implantation in Coronary Calcification

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Intravascular ultrasound
* Procedure: Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: Age less than 18-year-old; Comorbidity with a life expectancy <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 < 25%; Uremia dependent on dialysis treatment; Previous drug-eluting stent implantation in target vessel;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravascular ultrasound guidance<br> | Procedure: Intravascular ultrasound<br>* Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.<br>|
| Active Comparator: Angiography guidance<br> | Procedure: Angiography<br>* Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of target-vessel failure at 12 months | the composite of cardiovascular death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization | 12 months after indexed procedure |