IVUS CHIP UPP Registry

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

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Disease Risk High; Complex Coronary Artery Disease
• Intervention / Treatment: Device: IVUS

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.

• Study Type: Observational
• Enrollment (Estimated): 1010

Contacts and Locations

• Study Contact: Name: Chantal Bakker; Phone Number: 31+102062828; Email: CBakker@cardialysis.nl
• Study Contact Backup: Name: Ernest Spitzer, MD; Phone Number: 31+102062828; Email: e.spitzer@ecri-trials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients self-identified within a US census-defined minority with indication for IVUS-guided PCI of complex coronary lesions are consented for entering into the registry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: IVUS; Intravascular Ultrasound

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ECRI bv
• Collaborators: Boston Scientific Corporation; Cardialysis B.V.
• Investigators: Principal Investigator: David E Kandzari, MD, Piedmont Heart Institute; Study Director: Ernest Spitzer, MD, European Cardiovascular Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: PCI; intravascular ultrasound; CHIP; ivus-guidance
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: ECRI-14-US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes