IVUS CHIP UPP Registry

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06625801

Enrollment

1010

Registered

2024-10-03

Start date

2025-09-30

Completion date

2029-03-31

Last updated

2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Artery Disease Risk High, Complex Coronary Artery Disease

Keywords

PCI, intravascular ultrasound, CHIP, ivus-guidance

Brief summary

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.

Detailed description

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.

Interventions

DEVICEIVUS

Intravascular Ultrasound

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. The patient must be ≥18 years of age and self-identify within a US census-defined minority 2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria: 1. Angiographic heavy calcification 2. Ostial lesions 3. True bifurcation lesions involving side-branches >2.5mm 4. Left main lesions 5. Chronic total occlusion 6. In-stent restenosis 7. 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 3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS) 4. All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons 5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion 6. 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

1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days 2. Known untreated severe valvular heart disease 3. Contraindication on the use of IVUS (i.e. extreme vessel tortuosity) 4. Requiring PCI in a diseased aorto-coronary bypass 5. Known contraindication or hypersensitivity to anticoagulants 6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors 7. Non-cardiac co-morbidities with a life expectancy less than 1 year 8. 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.

Design outcomes

Primary

Measure	Time frame	Description
Target-vessel failure (TVF)	1 year after enrollment	TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization

Contacts

Primary ContactChantal Bakker

CBakker@cardialysis.nl31+102062828

Backup ContactErnest Spitzer, MD

e.spitzer@ecri-trials.com31+102062828

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026