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Clinical Trials in the USA / NCT06625801
Recruiting Observational

IVUS CHIP UPP Registry

NCT06625801 · tracked via the Priya Life Science USA tracker
Sponsor
ECRI bv
Phase
Observational
Started
2025-09-30
Last updated
2026-09-23

Condition(s) studied

Coronary Artery DiseaseCoronary Artery Disease Risk HighComplex Coronary Artery Disease

Investigational drug(s) / intervention(s)

IVUS

IVUS: Intravascular Ultrasound

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Banner Health Phoenix Arizona Recruiting
Loma Linda University Health Loma Linda California Recruiting
Baptist Health Coral Gables Florida Recruiting
Advent Health Orlando Florida Not Yet Recruiting
Advent Health Tampa Florida Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Emory University Hospital Midtown Atlanta Georgia Recruiting
Piedmont Heart Institute Atlanta Georgia Recruiting
Emory University Hospital Atlanta Georgia Not Yet Recruiting
Emory Saint Joseph's Hospital Midtown Atlanta Georgia Not Yet Recruiting
University of Illinois Chicago Illinois Not Yet Recruiting
Norton Healthcare Louisville Kentucky Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Essentia Institute of Rural Health Duluth Minnesota Recruiting
Jackson Heart Clinic Jackson Mississippi Recruiting
Barnabas Health Jersey City New Jersey Recruiting
Virtua Health Marlton New Jersey Recruiting
Rhode Island Hospital Providence Rhode Island Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06625801 on ClinicalTrials.gov ↗ ← All trials in the USA