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NCT Number: NCT05800002

IVUS-guided DES Implantation in Coronary Calcification

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Shaoliang Chen, MD

CONTACT

[email protected]

13605157029

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Intravascular ultrasound

Procedure

Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.

angiography

Procedure

Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.

Primary outcomes

  1. the rate of target-vessel failure at 12 months

    Time frame: 12 months after indexed procedure

    the composite of cardiovascular death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization

Study contacts

Contact information is provided by the study sponsor or research team.

Jun-Jie Zhang, MD

CONTACT

[email protected]

025-52271350

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: ULTIMATE IV

Important dates

Study start
2023
Primary completion
2026
Study completion
2033
First posted
Apr 5, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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