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Could a 3D image replace the wire in heart procedures?

NCT ID NCT05893498

Disease control Sponsor: CathWorks Ltd. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study compares a new software tool called FFRangio, which uses 3D X-ray images to assess heart artery blockages, against the standard invasive pressure wire method. About 1,924 adults with coronary artery disease are participating. The goal is to see if the software-guided treatment is as safe and effective as the wire-guided approach.

What this could mean

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

Active substance
FFRangio (software device) and pressure wire
What this could lead to
If successful, this could offer a less invasive way to guide heart artery treatment, potentially reducing complications from pressure wires.
What could go wrong
This is a non-inferiority trial, so it may only show the software is not worse than the standard, not necessarily better. The results may not apply to all patients 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,924 people

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

Started

Jun 2023

Expected to finish

May 2026

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.

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\. Adult patients (≥18 years of age) with one or more study lesion(s) (diameter stenosis 50-90%) deemed appropriate for both pressure-wire and FFRangio physiologic assessment. General Exclusion Criteria: 1. Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment 2. Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s) 3. Patients undergoing coronary physiologic assessment where one possible outcome is referral for CABG 4. The study vessel supplies a significant nonviable territory (e.g., prior transmural MI) 5. Severe left sided valvular heart disease 6. Most recent documented LVEF ≤30% 7. Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure) 8. Patients with life expectancy \<1 year life as estimated by treating physician. 9. Subjects enrolled in other ongoing non-registry clinical studies that would impact conduct or outcomes of this study (registries and long-term follow-up of other studies are allowed) 10. Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment. Angiographic Exclusion Criteria: 1. Coronary angiogram is not acquired per instructions as defined in the Study Protocol 2. Sthe study lesion is the clear culprit for a NSTEACS 3. Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization 4. Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment 5. The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta 6. The study lesion involves the left main coronary artery (stenosis ≥ 50%) 7. The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Percutaneous coronary intervention

Contacts and locations

Locations

  • Archbold Hospital

    Thomasville, Georgia, 31792, United States

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

  • Ascension Via Christi St. Francis

    Wichita, Kansas, 67214, United States

  • Basildon University Hospital

    Basildon, United Kingdom

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cardiac & Vascular Institute

    Gainesville, Florida, 32605, United States

  • Cardiac Associates Research

    Tupelo, Mississippi, 38801, United States

  • Carle Foundation Hospital

    Urbana, Illinois, 61801, United States

  • Chibanishi General Hospital

    Matsudo, Japan

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Ellis Hospital

    Schenectady, New York, 12308, United States

  • Fukuyama Cardiovascular Hospital

    Fukuyama, Japan

  • Gifu Heart Center

    Gifu, Japan

  • Golda HaSharon Hospital

    Petah Tikva, 49372, Israel

  • HCA Florida JFK Hospital

    Atlantis, Florida, 33462, United States

  • HCA Florida Northside Hospital

    St. Petersburg, Florida, 33709, United States

  • HCA Methodist Healthcare of San Antonio

    San Antonio, Texas, 78249, United States

  • Hopitaux Universitaires Geneve (HUG)

    Geneva, Switzerland

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Hôpital Cantonal de Fribourg (HFR)

    Villars-sur-Glâne, Switzerland

  • Ichinomiyanishi Hospital

    Ichinomiya, Japan

  • Imperial College Healthcare

    London, W12 0HS, United Kingdom

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031, United States

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118, United States

  • Kansas Heart Hospital

    Wichita, Kansas, 67226, United States

  • Keck Medicine of USC

    Los Angeles, California, 90033, United States

  • Kobe University

    Kobe, Japan

  • Lehigh Valley Health

    Allentown, Pennsylvania, 18103, United States

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Metropolitan Heart Vascular Institute

    Coon Rapids, Minnesota, 55433, United States

  • Mie University Hospital

    Osaka, Japan

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Carmel Health System

    Columbus, Ohio, 43219, United States

  • Mountainside Medical Center

    Montclair, New Jersey, 07042, United States

  • Musgrove Park Hospital

    Taunton, United Kingdom

  • NTT Medical Center Tokyo

    Tokyo, Japan

  • NYU Langone Health

    New York, New York, 10016, United States

  • New York Presbyterian / Weill Cornell Medical Center

    New York, New York, 10065, United States

  • New York Presbyterian Methodist Hospital

    Brooklyn, New York, 11215, United States

  • Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island))

    New York, New York, 10075, United States

  • Rabin Medical Centre

    Petah Tikva, 4941492, Israel

  • Sakakibara Heart Institute

    Tokyo, Japan

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • St. Francis Hospital and Heart Center

    Roslyn, New York, 11576, United States

  • St. Joesph's Medical Center

    Stockton, California, 95204, United States

  • Stanford University

    Palo Alto, California, 94305, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • TidalHealth, INC

    Salisbury, Maryland, 21801, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • University of California San Diego Health

    La Jolla, California, 92037, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • VA - Palo Alto Healthcare

    Palo Alto, California, 94305, United States

  • VA- Long Beach Healthcare

    Long Beach, California, 90822, United States

  • centre hospitalier universitaire vaudois (CHUV)

    Lausanne, CH-1011, Switzerland

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