IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
NCT ID: NCT04221815
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
3100 participants
INTERVENTIONAL
2020-10-14
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IVUS guided PCI
Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS
Eagle Eye Platinum digital IVUS catheter with optional SyncVision
IVUS catheter
Resolute Onyx Drug Eluting Stent
Stent
Onyx Frontier Drug Eluting Stent
Stent
Onyx TruStar Drug Eluting Stent
Stent
Onyx TruCor Drug Eluting Stent
Stent
Angiographic-guided PCI
Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator
Resolute Onyx Drug Eluting Stent
Stent
Onyx Frontier Drug Eluting Stent
Stent
Onyx TruStar Drug Eluting Stent
Stent
Onyx TruCor Drug Eluting Stent
Stent
Interventions
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Eagle Eye Platinum digital IVUS catheter with optional SyncVision
IVUS catheter
Resolute Onyx Drug Eluting Stent
Stent
Onyx Frontier Drug Eluting Stent
Stent
Onyx TruStar Drug Eluting Stent
Stent
Onyx TruCor Drug Eluting Stent
Stent
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Ron Waksman, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Health
Locations
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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
Countries
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References
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Shlofmitz E, Torguson R, Mintz GS, Zhang C, Sharp A, Hodgson JM, Shah B, Kumar G, Singh J, Inderbitzen B, Weintraub WS, Garcia-Garcia HM, Di Mario C, Waksman R. The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale. Am Heart J. 2020 Oct;228:65-71. doi: 10.1016/j.ahj.2020.08.002. Epub 2020 Aug 8.
Other Identifiers
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IMPROVE
Identifier Type: -
Identifier Source: org_study_id
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