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Heart stent study: can ultrasound cut repeat procedures?

NCT ID NCT04221815

Disease control Sponsor: Medstar Health Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study compares two ways to guide heart stent placement in people with complex artery blockages: using ultrasound (IVUS) versus standard X-ray. About 3,100 participants will be randomly assigned to one method. The goal is to see if ultrasound leads to larger stent openings and fewer heart-related problems like heart attacks or repeat procedures over 12 months.

What this could mean

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

Active substance
IVUS catheter and drug-eluting stents
What this could lead to
If successful, this could show that using ultrasound during stent placement reduces heart attacks and the need for repeat procedures in people with complex blockages.
What could go wrong
This is a large but still ongoing trial; results are not yet final. The benefit may be small or not apply to all patients, and ultrasound adds time and cost to the procedure.

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 3,100 people

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

Started

Oct 2020

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age ≥ 18 years at screening * PCI with stent implantation involving a high risk or complex lesion defined as involving at least one of the following characteristics: * Chronic total occlusion * In-stent restenosis * Severe coronary artery calcification * Long lesion (≥ 28 mm in length) * Bifurcation lesion (Any Medina class that involves main branch disease with a side branch ≥2.0 mm) * Stable angina, unstable angina, or non-ST Elevation myocardial infarction (NSTEMI), undergoing PCI of a single or multivessel coronary artery stenosis * PCI performed with either angiography alone, or IVUS guidance used Exclusion Criteria: * Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock * Use of fibrinolytic therapy within 24 hours of PCI * Planned revascularization of a target vessel as a staged procedure * Stent thrombosis * Use of optical coherence tomography (OCT) during the index procedure

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Conditions

The condition(s) this trial relates to.

atherosclerosis

As listed by the trial registrant

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

Atherosclerosis

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • AdventHealth Sebring

    Sebring, Florida, 33870, United States

  • Ascension Sacred Heart

    Pensacola, Florida, 32504, United States

  • Ascension St. John

    Dearborn, Michigan, 48124, United States

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033, United States

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Carle Foundation Hospital

    Urbana, Illinois, 61801, United States

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205, United States

  • Danderyd University Hospital

    Stockholm, 18288, Sweden

  • Emory

    Atlanta, Georgia, 30322, United States

  • Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, NE77DN, United Kingdom

  • General Hospital of Athens Hippokration

    Athens, 11634, Greece

  • Good Samaritan University Hospital

    West Islip, New York, 11795, United States

  • Helios Amper-Klinikum Dachau

    Dachau, 85221, Germany

  • Herz-und Diabeteszentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Imperial College Healthcare

    London, W120HS, United Kingdom

  • Leeds General Infirmary

    Leeds, West Yorkshire, LS13EX, United Kingdom

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • Manatee Memorial Hospital

    Bradenton, Florida, 34205, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland, 20735, United States

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • MercyOne Iowa Heart Center

    Des Moines, Iowa, 50314, United States

  • NYU Langone Hospital

    Brooklyn, New York, 11220, United States

  • Nicosia General Hospital

    Nicosia, Cyprus

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501, United States

  • Northwell Health - Lennox Hill Hospital

    New York, New York, 10075, United States

  • Northwell Health - North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Northwell Health - South Shore University Hospital

    Bay Shore, New York, 11706, United States

  • Northwest Medical Center

    Tucson, Arizona, 85741, United States

  • Rheinland Klinikum

    Neuss, 41464, Germany

  • Riverside Medical Center

    Kankakee, Illinois, 60901, United States

  • Rush University Medial Center

    Chicago, Illinois, 60612, United States

  • Sahlgrenska University Hospital

    Gothenburg, 41345, Sweden

  • San Antonio Regional Hospital

    Upland, California, 91786, United States

  • San Francisco VA Health Care System

    San Francisco, California, 94121, United States

  • Segerberger Kliniken

    Bad Segeberg, 23795, Germany

  • Seton Medical Center Austin

    Austin, Texas, 78705, United States

  • Shamir Medical Center

    Be’er Ya‘aqov, 7030000, Israel

  • Skane University Hospital

    Lund, 22185, Sweden

  • St. Francis

    Roslyn, New York, 11576, United States

  • St. Luke's Hospital of Duluth

    Duluth, Minnesota, 55805, United States

  • St. Vinzenz Hospital

    Cologne, North Rhine-Westphalia, 50733, Germany

  • Tampa Cardiovascular/St. Joseph's Hospital

    Tampa, Florida, 33614, United States

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905, United States

  • The Ohio State University Medical Center

    Columbus, Ohio, 43201, United States

  • The University General Hospital of Ioannina

    Ioannina, 45500, Greece

  • Thriassion General Hospital

    Magoula, 19600, Greece

  • University Hospital Careggi

    Florence, 50134, Italy

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • University Medicine Rostock

    Rostock, D-18057, Germany

  • University of California San Deigo

    La Jolla, California, 92037, United States

  • University of Messina

    Messina, 98124, Italy

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina Rex Hospital

    Raleigh, North Carolina, 27607, United States

  • Virtua Our Lady of Lourdes Hospital

    Camden, New Jersey, 08103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.