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Recruiting NCT06274645

IVUS CHIP China Registry

— Observational Complex Higher Risk Indicated Patients Undergoing PCI

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: The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific.
Who it may be relevant to
Registry conditions: Complex Higher Risk Indicated Patients Undergoing PCI. 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific
    The IVUS-guided PCI procedure includes the use of IVUS before PCI (highly recommended) and after PCI (mandatory)

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Time-to-first-event analysis will be primarily used for clinical endpoints. [Time frame: full-time process until 2 Year]

Eligibility criteria

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)

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fudan Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT06274645 · IVUS CHIP China Registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗