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

Last updated: September 8, 2025
Sponsor: Medstar Health Research Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Atherosclerosis

Treatment

Resolute Onyx Drug Eluting Stent

Onyx TruStar Drug Eluting Stent

Onyx TruCor 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: Resolute Onyx Drug Eluting Stent
Phase:
Study Start date:
October 14, 2020
Estimated Completion Date:
September 30, 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

  • Nicosia General Hospital

    Nicosia 146268,
    Cyprus

    Site Not Available

  • Herz-und Diabeteszentrum NRW

    Bad Oeynhausen, NRW 32545
    Germany

    Site Not Available

  • St. Vinzenz Hospital

    Cologne, North Rhine Westphalia 50733
    Germany

    Site Not Available

  • Herz-und Diabeteszentrum NRW

    Bad Oeynhausen 2953386, North Rhine-Westphalia 2861876 32545
    Germany

    Site Not Available

  • St. Vinzenz Hospital

    Cologne 2886242, North Rhine-Westphalia 2861876 50733
    Germany

    Site Not Available

  • Segerberger Kliniken

    Bad Segeberg, 23795
    Germany

    Site Not Available

  • Segerberger Kliniken

    Bad Segeberg 2953341, 23795
    Germany

    Site Not Available

  • DRK Kliniken Berlin Köpenik

    Berlin, 12559
    Germany

    Site Not Available

  • Helios Amper-Klinikum Dachau

    Dachau, 85221
    Germany

    Site Not Available

  • Helios Amper-Klinikum Dachau

    Dachau 2939623, 85221
    Germany

    Site Not Available

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • University Medical Center Hamburg-Eppendorf

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Rheinland Klinikum

    Neuss, 41464
    Germany

    Site Not Available

  • Rheinland Klinikum

    Neuss 2864118, 41464
    Germany

    Site Not Available

  • University Medicine Rostock

    Rostock, D-18057
    Germany

    Site Not Available

  • University Medicine Rostock

    Rostock 2844588, D-18057
    Germany

    Site Not Available

  • General Hospital of Athens Hippokration

    Athens, 11634
    Greece

    Site Not Available

  • General Hospital of Athens Hippokration

    Athens 264371, 11634
    Greece

    Site Not Available

  • The University General Hospital of Ioannina

    Ioannina 261779, 45500
    Greece

    Site Not Available

  • Thriassion General Hospital

    Magoula 258007, 19600
    Greece

    Site Not Available

  • Thriassion General Hospital

    Magoúla, 19600
    Greece

    Site Not Available

  • Shamir Medical Center

    Be'er Ya'aqov, 7030000
    Israel

    Site Not Available

  • Shamir Medical Center

    Be’er Ya‘aqov 295525, 7030000
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba 294514, 4428164
    Israel

    Site Not Available

  • University Hospital Careggi

    Florence, 50134
    Italy

    Site Not Available

  • University Hospital Careggi

    Florence 3176959, 50134
    Italy

    Site Not Available

  • University of Messina

    Messina, 98124
    Italy

    Site Not Available

  • University of Messina

    Messina 2524170, 98124
    Italy

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg, 41345
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Gothenburg 2711537, 41345
    Sweden

    Site Not Available

  • Skane University Hospital

    Lund, 22185
    Sweden

    Site Not Available

  • Skane University Hospital

    Lund 2693678, 22185
    Sweden

    Site Not Available

  • Danderyd University Hospital

    Stockholm, 18288
    Sweden

    Site Not Available

  • Danderyd University Hospital

    Stockholm 2673730, 18288
    Sweden

    Site Not Available

  • Freeman Hospital

    Newcastle Upon Tyne, Tyne And Wear NE77DN
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle upon Tyne 2641673, Tyne and Wear NE77DN
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds, West Yorkshire LS13EX
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds 2644688, West Yorkshire LS13EX
    United Kingdom

    Site Not Available

  • Imperial College Healthcare

    London, W120HS
    United Kingdom

    Site Not Available

  • Imperial College Healthcare

    London 2643743, W120HS
    United Kingdom

    Site Not Available

  • Northwest Medical Center

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Northwest Medical Center

    Tucson 5318313, Arizona 5551752 85741
    United States

    Site Not Available

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Central Arkansas Veterans Healthcare System

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • University of California San Deigo

    La Jolla, California 92037
    United States

    Site Not Available

  • San Francisco VA Health Care System

    San Francisco, California 94121
    United States

    Site Not Available

  • San Antonio Regional Hospital

    Upland, California 91786
    United States

    Site Not Available

  • University of California San Deigo

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • San Francisco VA Health Care System

    San Francisco 5391959, California 5332921 94121
    United States

    Site Not Available

  • San Antonio Regional Hospital

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Manatee Memorial Hospital

    Bradenton, Florida 34205
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Ascension Sacred Heart

    Pensacola, Florida 32504
    United States

    Site Not Available

  • AdventHealth Sebring

    Sebring, Florida 33870
    United States

    Site Not Available

  • Tampa Cardiovascular/St. Joseph's Hospital

    Tampa, Florida 33614
    United States

    Site Not Available

  • Manatee Memorial Hospital

    Bradenton 4148708, Florida 4155751 34205
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Ascension Sacred Heart

    Pensacola 4168228, Florida 4155751 32504
    United States

    Site Not Available

  • AdventHealth Sebring

    Sebring 4172383, Florida 4155751 33870
    United States

    Site Not Available

  • Tampa Cardiovascular/St. Joseph's Hospital

    Tampa 4174757, Florida 4155751 33614
    United States

    Site Not Available

  • Emory

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Atlanta VA Medical Center

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Emory

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Atlanta VA Medical Center

    Decatur 4191124, Georgia 4197000 30033
    United States

    Site Not Available

  • Northeast Georgia Medical Center

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Site Not Available

  • Rush University Medial Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Riverside Medical Center

    Kankakee, Illinois 60901
    United States

    Site Not Available

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Rush University Medial Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Riverside Medical Center

    Kankakee 4898182, Illinois 4896861 60901
    United States

    Site Not Available

  • Carle Foundation Hospital

    Urbana 4914570, Illinois 4896861 61801
    United States

    Site Not Available

  • MercyOne Iowa Heart Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • MercyOne Iowa Heart Center

    Des Moines 4853828, Iowa 4862182 50314
    United States

    Site Not Available

  • MedStar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland 20735
    United States

    Site Not Available

  • MedStar Union Memorial Hospital

    Baltimore 4347778, Maryland 4361885 21218
    United States

    Site Not Available

  • MedStar Southern Maryland Hospital Center

    Clinton 4351871, Maryland 4361885 20735
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield 4951788, Massachusetts 6254926 01199
    United States

    Site Not Available

  • Ascension St. John

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • Ascension St. John

    Dearborn 4990510, Michigan 5001836 48124
    United States

    Site Not Available

  • St. Luke's Hospital of Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • St. Luke's Hospital of Duluth

    Duluth 5024719, Minnesota 5037779 55805
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Site Not Available

  • Virtua Our Lady of Lourdes Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey 08240
    United States

    Site Not Available

  • Virtua Our Lady of Lourdes Hospital

    Camden 4501018, New Jersey 5101760 08103
    United States

    Site Not Available

  • AtlantiCare Regional Medical Center

    Pomona 4503665, New Jersey 5101760 08240
    United States

    Site Not Available

  • Northwell Health - South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Site Not Available

  • NYU Langone Hospital

    Brooklyn, New York 11220
    United States

    Site Not Available

  • Northwell Health - North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Northwell Health - Lennox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • St. Francis

    Roslyn, New York 11576
    United States

    Site Not Available

  • SUNY Upstate Medical Center

    Syracuse, New York 13210
    United States

    Site Not Available

  • Good Samaritan University Hospital

    West Islip, New York 11795
    United States

    Site Not Available

  • Northwell Health - South Shore University Hospital

    Bay Shore 5108169, New York 5128638 11706
    United States

    Site Not Available

  • NYU Langone Hospital

    Brooklyn 5110302, New York 5128638 11220
    United States

    Site Not Available

  • Northwell Health - North Shore University Hospital

    Manhasset 5125766, New York 5128638 11030
    United States

    Site Not Available

  • Northwell Health - Lennox Hill Hospital

    New York 5128581, New York 5128638 10075
    United States

    Site Not Available

  • St. Francis

    Roslyn 5134415, New York 5128638 11576
    United States

    Site Not Available

  • Good Samaritan University Hospital

    West Islip 5143866, New York 5128638 11795
    United States

    Site Not Available

  • University of North Carolina Rex Hospital

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • University of North Carolina Rex Hospital

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • The Ohio State University Medical Center

    Columbus, Ohio 43201
    United States

    Site Not Available

  • The Ohio State University Medical Center

    Columbus 4509177, Ohio 5165418 43201
    United States

    Site Not Available

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Lehigh Valley Hospital

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Site Not Available

  • Seton Medical Center Austin

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • San Antonio Regional Hospital

    San Antonio, Texas 91786
    United States

    Site Not Available

  • Seton Medical Center Austin

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso 5520993, Texas 4736286 79905
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke 4782167, Virginia 6254928 24014
    United States

    Site Not Available

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