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NCT Number: NCT06625801

IVUS CHIP UPP Registry

The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women. All patients will be treated with IVUS-guided PCI.

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Key information

About this study

Objective is to describe in a United States population the clinical efficacy and safety of an IVUS-guided approach in patients who self-identify within a census-defined minority undergoing PCI of complex coronary lesions, as well as clinical outcomes up to 2 years.

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 and self-identify within a US census-defined minority
  • 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 FDA-approved contemporary generation drug eluting stents or drug-coated balloons
  • 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 (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB

Exclusion criteria

  • ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
  • Known untreated severe valvular heart disease
  • Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)
  • 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
  • A patients that is currently participating in a clinical trial that has not yet reached its primary endpoint cannot be included in this registry. A patient may only be enrolled in this registry once.

Treatment and study plan

IVUS

Device

Intravascular Ultrasound

Primary outcomes

  1. Target-vessel failure (TVF)

    Time frame: 1 year after enrollment

    TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization

Study contacts

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

Chantal Bakker

CONTACT

[email protected]

31+102062828

Ernest Spitzer, MD

CONTACT

[email protected]

31+102062828

Sponsors and collaborators

Lead sponsor

ECRI bv

Industry

Collaborators

  • Boston Scientific Corporation
  • Cardialysis B.V.

Registry information

Official study title

Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures in Underrepresented Patient Populations Registry

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 3, 2024
Registry last updated
Sep 2, 2025

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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