IVUS CHIP UPP Registry

NCT ID: NCT06625801

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1010 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2029-03-31

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.

Conditions

Coronary Artery Disease; Coronary Artery Disease Risk High; Complex Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

IVUS

Intervention Type: DEVICE

Intravascular Ultrasound

Interventions

IVUS

Intravascular Ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Cardialysis B.V.

INDUSTRY

Sponsor Role: collaborator

ECRI bv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ernest Spitzer, MD

Role: STUDY_DIRECTOR

European Cardiovascular Research Institute

David E Kandzari, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Central Contacts

Chantal Bakker

Role: CONTACT

CBakker@cardialysis.nl

31+102062828

Ernest Spitzer, MD

Role: CONTACT

e.spitzer@ecri-trials.com

31+102062828

Other Identifiers

ECRI-14-US

Identifier Type: -

Identifier Source: org_study_id