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ACTIVE NOT RECRUITING
NCT04221815
NA

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

Sponsor: Medstar Health Research Institute

View on ClinicalTrials.gov

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.

Official title: IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3100

Start Date

2020-10-14

Completion Date

2027-09

Last Updated

2025-09-12

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Eagle Eye Platinum digital IVUS catheter with optional SyncVision

IVUS catheter

DEVICE

Resolute Onyx Drug Eluting Stent

Stent

DEVICE

Onyx Frontier Drug Eluting Stent

Stent

DEVICE

Onyx TruStar Drug Eluting Stent

Stent

DEVICE

Onyx TruCor Drug Eluting Stent

Stent

Locations (61)

Northwest Medical Center

Tucson, Arizona, United States

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

University of California San Deigo

La Jolla, California, United States

San Francisco VA Health Care System

San Francisco, California, United States

San Antonio Regional Hospital

Upland, California, United States

Medstar Washington Hospital Center

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

Manatee Memorial Hospital

Bradenton, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

AdventHealth Sebring

Sebring, Florida, United States

Tampa Cardiovascular/St. Joseph's Hospital

Tampa, Florida, United States

Emory

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Rush University Medial Center

Chicago, Illinois, United States

Riverside Medical Center

Kankakee, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

MercyOne Iowa Heart Center

Des Moines, Iowa, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

MedStar Southern Maryland Hospital Center

Clinton, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Ascension St. John

Dearborn, Michigan, United States

St. Luke's Hospital of Duluth

Duluth, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Virtua Our Lady of Lourdes Hospital

Camden, New Jersey, United States

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States

Northwell Health - South Shore University Hospital

Bay Shore, New York, United States

NYU Langone Hospital

Brooklyn, New York, United States

Northwell Health - North Shore University Hospital

Manhasset, New York, United States

Northwell Health - Lennox Hill Hospital

New York, New York, United States

St. Francis

Roslyn, New York, United States

Good Samaritan University Hospital

West Islip, New York, United States

University of North Carolina Rex Hospital

Raleigh, North Carolina, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Seton Medical Center Austin

Austin, Texas, United States

Texas Tech University Health Sciences Center

El Paso, Texas, United States

Carilion Clinic

Roanoke, Virginia, United States

Nicosia General Hospital

Nicosia, Cyprus

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

St. Vinzenz Hospital

Cologne, North Rhine-Westphalia, Germany

Segerberger Kliniken

Bad Segeberg, Germany

Helios Amper-Klinikum Dachau

Dachau, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Rheinland Klinikum

Neuss, Germany

University Medicine Rostock

Rostock, Germany

General Hospital of Athens Hippokration

Athens, Greece

The University General Hospital of Ioannina

Ioannina, Greece

Thriassion General Hospital

Magoula, Greece

Shamir Medical Center

Be’er Ya‘aqov, Israel

Meir Medical Center

Kfar Saba, Israel

University Hospital Careggi

Florence, Italy

University of Messina

Messina, Italy

Sahlgrenska University Hospital

Gothenburg, Sweden

Skane University Hospital

Lund, Sweden

Danderyd University Hospital

Stockholm, Sweden

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Leeds General Infirmary

Leeds, West Yorkshire, United Kingdom

Imperial College Healthcare

London, United Kingdom