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Recruiting NCT05800002

IVUS-guided DES Implantation in Coronary Calcification

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravascular ultrasound, Angiography.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Intravascular ultrasound
    Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.
  • Procedure Angiography
    Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.

Primary outcome measures

  • the rate of target-vessel failure at 12 months [Time frame: 12 months after indexed procedure]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing First Hospital — Nanjing

Identifiers

NCT: NCT05800002 · KY20230310-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗