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RecruitingNCT06625801Updated Sep 23, 2026

IVUS CHIP UPP Registry

An observational study in Coronary Artery Disease, Coronary Artery Disease Risk High and Complex Coronary Artery Disease, sponsored by ECRI bv. Recruiting at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by ECRI bv · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,010
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Disease
  • Coronary Artery Disease Risk High
  • Complex Coronary Artery Disease

Keywords

  • PCI
  • intravascular ultrasound
  • CHIP
  • ivus-guidance
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 1,010 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

ECRI bv is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 prior to any protocol-related procedure, as approved by the appropriate IRB

Exclusion criteria

Exclusion Criteria:

  1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
  2. Known untreated severe valvular heart disease
  3. on the use of IVUS (i.e. extreme vessel tortuosity)
  4. Requiring PCI in a diseased aorto-coronary bypass
  5. Known contraindication or 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,010 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceIVUS

    Intravascular Ultrasound

06

What researchers measure

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

    Time frame: 1 year after enrollment

07

Study locations

13 of 18 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2028, 36 months after the start.

Of 125 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 36 months is above that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2024
First posted
Oct 3, 2024
StartActual
Sep 30, 2025
Primary completionEst.
Sep 30, 2028
CompletionEst.
Mar 2029
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06625801
Lead sponsor
ECRI bv
Collaborators
Boston Scientific Corporation, Cardialysis B.V.
Responsible party
Sponsor
First posted
Oct 3, 2024
Start date
Sep 30, 2025
Primary completion
Sep 30, 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Chantal Bakker
Contact
CBakker@cardialysis.nl
31+102062828
Ernest Spitzer, MD
Contact
e.spitzer@ecri-trials.com
31+102062828
Ernest Spitzer, MD
study director · European Cardiovascular Research Institute
David E Kandzari, MD
principal investigator · Piedmont Heart Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

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