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Recruiting

NCT Number: NCT06274645

IVUS CHIP China Registry

The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan Zhongshan Hospital

Shanghai, China

Location status: Recruiting

Location contact

Chenguang Li, Doctor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient must be ≥18 years of age
  • Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
  • Angiographic heavy calcification
  • Ostial lesions
  • True bifurcation lesions involving side-branches >2.5mm
  • Left main lesions
  • Chronic total occlusion
  • In-stent restenosis
  • Long-lesions (estimated stent length > 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
  • Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
  • All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions)
  • The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
  • Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee

Exclusion criteria

  • ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
  • Known untreated severe valvular heart disease
  • Requiring PCI in a diseased aorto-coronary bypass
  • Known contraindication or hypersensitivity to anticoagulants
  • Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
  • Non-cardiac co-morbidities with a life expectancy less than 1 year
  • Currently participating in a clinical trial that is not yet at its primary endpoint. The patient is not allowed to participate in an investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
  • Women who are pregnant or who are breastfeeding
  • Subject's circumstances that will not allow appropriate consenting procedures or follow-up activities (per investigator's discretion)

Treatment and study plan

The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific

Device

The IVUS-guided PCI procedure includes the use of IVUS before PCI (highly recommended) and after PCI (mandatory)

Primary outcomes

  1. Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints.

    Time frame: 1 Year

    Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-vessel revascularization at 1 year. It means the time of the patient's occurrence of any of the three events in one year.

Secondary outcomes

  1. Time-to-first-event analysis will be primarily used for clinical endpoints.

    Time frame: full-time process until 2 Year

    • The time of the first event of Composite of target-vessel myocardial infarction* and clinically indicated target vessel revascularization
    • The time of the first event of Clinically-indicated target vessel revascularization
    • The time of the first event of Composite of cardiac death and target-vessel myocardial infarction*
    • The time of the first event of Target-Lesion Failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-lesion revascularization
    • The time of the first event of Target-lesion revascularization
    • The time of Cardiac death

Study contacts

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

Chenguang Li, Doctor

CONTACT

[email protected]

86+ 13816767665

Junbo Ge, Doctor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures China Registry

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Feb 23, 2024
Registry last updated
Apr 26, 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.