IVUS CHIP UPP Registry

NCT06625801 | Not Yet Recruiting FDA Device

• 1 other identifier: ECRI-14-US
• Study Type: observational
• Target: 1,010
• Locations: 0 countries
• Sites: N/A

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

Keywords

PCI; intravascular ultrasound; CHIP; ivus-guidance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

IVUS DEVICE

Intravascular Ultrasound

IVUS-guided PCI in patients traditionally underrepresented in clinical trials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ECRI bv: lead
• Boston Scientific Corporation: collaborator
• Cardialysis B.V.: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ernest Spitzer, MD

  European Cardiovascular Research Institute

  STUDY DIRECTOR

• David E Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Bakker

CONTACT

31+102062828; CBakker@cardialysis.nl

Ernest Spitzer, MD

CONTACT

31+102062828; e.spitzer@ecri-trials.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share