IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

Last updated: May 14, 2024
Sponsor: Medstar Health Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Treatment

Onyx TruCor Drug Eluting Stent

Eagle Eye Platinum digital IVUS catheter with optional SyncVision

Resolute Onyx Drug Eluting Stent

Clinical Study ID

NCT04221815
IMPROVE
  • Ages > 18
  • All Genders

Study Summary

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years at screening

  • PCI with stent implantation involving a high risk or complex lesion defined asinvolving 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 sidebranch ≥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

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

Study Design

Total Participants: 3100
Treatment Group(s): 5
Primary Treatment: Onyx TruCor Drug Eluting Stent
Phase:
Study Start date:
October 14, 2020
Estimated Completion Date:
August 31, 2027

Study Description

This is a prospective, single-blind clinical investigation randomizing subjects to IVUS-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio.

The clinical investigation will be conducted at approximately 120 centers in the US, Canada, and Europe. Approximately 2,500-3,100 randomized subjects and up to 3 roll-in subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 2 years. The expected duration of enrollment is approximately 2.5 years. The total duration of the clinical investigation is expected to be approximately 4.5 years.

Connect with a study center

  • Herz-und Diabeteszentrum NRW

    Bad Oeynhausen, NRW 32545
    Germany

    Active - Recruiting

  • St. Vinzenz Hospital

    Cologne, North Rhine Westphalia 50733
    Germany

    Active - Recruiting

  • Segerberger Kliniken

    Bad Segeberg, 23795
    Germany

    Active - Recruiting

  • DRK Kliniken Berlin Köpenik

    Berlin, 12559
    Germany

    Site Not Available

  • Helios Amper-Klinikum Dachau

    Dachau, 85221
    Germany

    Active - Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Rheinland Klinikum

    Neuss, 41464
    Germany

    Active - Recruiting

  • University Medicine Rostock

    Rostock, D-18057
    Germany

    Active - Recruiting

  • General Hospital of Athens Hippokration

    Athens, 11634
    Greece

    Active - Recruiting

  • Thriassion General Hospital

    Magoúla, 19600
    Greece

    Active - Recruiting

  • Shamir Medical Center

    Be'er Ya'aqov, 7030000
    Israel

    Active - Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Active - Recruiting

  • University Hospital Careggi

    Florence, 50134
    Italy

    Active - Recruiting

  • University of Messina

    Messina, 98124
    Italy

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 41345
    Sweden

    Active - Recruiting

  • Skane University Hospital

    Lund, 22185
    Sweden

    Active - Recruiting

  • Danderyd University Hospital

    Stockholm, 18288
    Sweden

    Active - Recruiting

  • Freeman Hospital

    Newcastle Upon Tyne, Tyne And Wear NE77DN
    United Kingdom

    Active - Recruiting

  • Leeds General Infirmary

    Leeds, West Yorkshire LS13EX
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare

    London, W120HS
    United Kingdom

    Active - Recruiting

  • Northwest Medical Center

    Tucson, Arizona 85741
    United States

    Active - Recruiting

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • University of California San Deigo

    La Jolla, California 92037
    United States

    Active - Recruiting

  • San Francisco VA Health Care System

    San Francisco, California 94121
    United States

    Active - Recruiting

  • San Antonio Regional Hospital

    Upland, California 91786
    United States

    Active - Recruiting

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Manatee Memorial Hospital

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • AdventHealth Sebring

    Sebring, Florida 33870
    United States

    Active - Recruiting

  • Tampa Cardiovascular/St. Joseph's Hospital

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Emory

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Atlanta VA Medical Center

    Decatur, Georgia 30033
    United States

    Active - Recruiting

  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Rush University Medial Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Riverside Medical Center

    Kankakee, Illinois 60901
    United States

    Active - Recruiting

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Active - Recruiting

  • MercyOne Iowa Heart Center

    Des Moines, Iowa 50314
    United States

    Terminated

  • MedStar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland 20735
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Active - Recruiting

  • Ascension St. John

    Dearborn, Michigan 48124
    United States

    Active - Recruiting

  • St. Luke's Hospital of Duluth

    Duluth, Minnesota 55805
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Virtua Our Lady of Lourdes Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey 08240
    United States

    Active - Recruiting

  • Northwell Health - South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Active - Recruiting

  • NYU Langone Hospital

    Brooklyn, New York 11220
    United States

    Active - Recruiting

  • Northwell Health - North Shore University Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Northwell Health - Lennox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • St. Francis

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • SUNY Upstate Medical Center

    Syracuse, New York 13210
    United States

    Site Not Available

  • Good Samaritan University Hospital

    West Islip, New York 11795
    United States

    Active - Recruiting

  • University of North Carolina Rex Hospital

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • The Ohio State University Medical Center

    Columbus, Ohio 43201
    United States

    Active - Recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Seton Medical Center Austin

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Active - Recruiting

  • San Antonio Regional Hospital

    San Antonio, Texas 91786
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.