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New study aims to improve heart procedure outcomes for minority patients

NCT ID NCT06625801

Knowledge-focused Sponsor: ECRI bv Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This registry will enroll 1010 minority patients with complex coronary artery disease to see if using intravascular ultrasound (IVUS) during stent placement improves outcomes. The study tracks heart-related death, heart attacks, and need for repeat procedures over time. It aims to gather real-world data on how IVUS guidance works in underrepresented populations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that using IVUS during heart procedures improves outcomes for minority patients and helps reduce healthcare disparities.
What could go wrong
This is an observational registry, not a randomized trial, so it cannot prove cause and effect. Results may not apply to all populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,010 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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