Coronary Artery DiseaseNCT06625801
IVUS CHIP UPP Registry
An observational study of Coronary Artery Disease and Coronary Artery Disease Risk High, run by ECRI bv at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Disease Risk High, Complex Coronary Artery Disease
- What is being tested?
- IVUS
- Type of treatment
- Medical device
- How many people
- 1,010 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Sep 2025to Mar 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
- Not yet recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Not yet recruiting
Emory Saint Joseph's Hospital Midtown
Atlanta, Georgia, 30342
- Not yet recruiting
University of Illinois
Chicago, Illinois, 60612
- Recruiting
Baptist Health
Coral Gables, Florida, 33143
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
- Recruiting
Jackson Heart Clinic
Jackson, Mississippi, 39216
- Recruiting
Barnabas Health
Jersey City, New Jersey, 07052
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
- Recruiting
Norton Healthcare
Louisville, Kentucky, 40202
- Recruiting
Virtua Health
Marlton, New Jersey, 08053
- Not yet recruiting
Advent Health
Orlando, Florida, 32803
- Recruiting
Banner Health
Phoenix, Arizona, 85006
- Not yet recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
- Recruiting
Advent Health
Tampa, Florida, 33613
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: 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.
Read the 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
- Being tested
- IVUS
- Keywords
- PCI, intravascular ultrasound, CHIP, ivus-guidance
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUSDevice
Intravascular Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target-vessel failure (TVF)
TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start30 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,010 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- ECRI bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Cardialysis B.V.
- Responsible party
- Sponsor
- Investigators
- Ernest Spitzer, MD, Study director, European Cardiovascular Research InstituteDavid E Kandzari, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625801
- Sponsor's protocol ID
- ECRI-14-US
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures in Underrepresented Patient Populations Registry
- ClinicalTrials.gov ID
- NCT06625801
- Acronym / sponsor ID
- ECRI-14-US
- Conditions
- Coronary Artery Disease, Coronary Artery Disease Risk High, Complex Coronary Artery Disease
- Keywords
- PCI, intravascular ultrasound, CHIP, ivus-guidance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,010 participants (estimated)
- Lead sponsor
- ECRI bvIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Cardialysis B.V.
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided PCI in patients traditionally underrepresented in clinical trials | – | Device: IVUSPatients undergoing IVUS-guided PCI for complex coronary artery disease who self-identify within a census-defined minority in the United States |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUSIntravascular Ultrasound | Device | IVUS-guided PCI in patients traditionally underrepresented in clinical trials |
Primary outcome
Target-vessel failure (TVF)
Time frame: 1 year after enrollment
TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ernest Spitzer, MD study director
European Cardiovascular Research Institute
David E Kandzari, MD principal investigator
Piedmont Heart Institute
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Artery Disease Risk High, run by ECRI bv at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal Bakker (31+102062828, CBakker@cardialysis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target-vessel failure (TVF) (time frame: 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.