Recruiting

IVUS-Guided PCI

Sponsor:

ECRI bv

Code:

NCT06625801

Conditions

Coronary Artery Disease

Coronary Artery Disease Risk High

Complex Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IVUS

Study Details

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.

Conditions

Coronary Artery Disease

Coronary Artery Disease Risk High

Complex Coronary Artery Disease

Study ID

NCT06625801

Start date

Sep 30, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1010 participants

Anticipated

Interventions and Outcome Measures

Arms

IVUS-guided PCI in patients traditionally underrepresented in clinical trials

Patients undergoing IVUS-guided PCI for complex coronary artery disease who self-identify within a census-defined minority in the United States

Interventions

IVUS

Intravascular Ultrasound

Primary outcome measure

  • Target-vessel failure (TVF) [ Time Frame: 1 year after enrollment ]

Central Contacts and Locations

Locations

Banner Health

Recruiting

Phoenix, Arizona, United States, 85006

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Baptist Health

Recruiting

Coral Gables, Florida, United States, 33143

Advent Health

Recruiting

Tampa, Florida, United States, 33613

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Norton Healthcare

Recruiting

Louisville, Kentucky, United States, 40202

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Essentia Institute of Rural Health

Recruiting

Duluth, Minnesota, United States, 55805

Jackson Heart Clinic

Recruiting

Jackson, Mississippi, United States, 39216

Barnabas Health

Recruiting

Jersey City, New Jersey, United States, 07052

Virtua Health

Recruiting

Marlton, New Jersey, United States, 08053

More Information

Sponsor

ECRI bv

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • PCI
  • intravascular ultrasound
  • CHIP
  • ivus-guidance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by ECRI bv on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.