IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
IMPROVE
1 other identifier
interventional
3,100
8 countries
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedStudy Start
First participant enrolled
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 12, 2025
September 1, 2025
5.9 years
December 27, 2019
September 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
IVUS core lab measures final PCI Minimum Stent Area
The imaging primary endpoint is the final post-PCI minimum stent area (MSA) assessed by IVUS in each randomized arm, measured at an independent IVUS core laboratory blinded to treatment assignment. The MSA is an appropriate co-primary imaging endpoint as it is the most consistent and strongest parameter to predict clinical outcomes.11-14 In the present study, after 2,000 subjects are enrolled with the procedure completed, the primary endpoint of MSA will be tested to compare the IVUS-guided and angiography-guided arms. If significantly larger MSA in the IVUS-guided arm is demonstrated, the trial will continue enrolling subjects.
Intra-procedural
Target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related-myocardial infarction (MI), and ischemia-driven target vessel revascularization.
The clinical primary endpoint is target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related- myocardial infarction (MI), and target vessel revascularization.
12 months
Study Arms (2)
IVUS guided PCI
ACTIVE COMPARATORPatients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS
Angiographic-guided PCI
PLACEBO COMPARATORPatients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Northwest Medical Center
Tucson, Arizona, 85741, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
University of California San Deigo
La Jolla, California, 92037, United States
San Francisco VA Health Care System
San Francisco, California, 94121, United States
San Antonio Regional Hospital
Upland, California, 91786, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Manatee Memorial Hospital
Bradenton, Florida, 34205, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
AdventHealth Sebring
Sebring, Florida, 33870, United States
Tampa Cardiovascular/St. Joseph's Hospital
Tampa, Florida, 33614, United States
Emory
Atlanta, Georgia, 30322, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Rush University Medial Center
Chicago, Illinois, 60612, United States
Riverside Medical Center
Kankakee, Illinois, 60901, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
MercyOne Iowa Heart Center
Des Moines, Iowa, 50314, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Ascension St. John
Dearborn, Michigan, 48124, United States
St. Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, 08103, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240, United States
Northwell Health - South Shore University Hospital
Bay Shore, New York, 11706, United States
NYU Langone Hospital
Brooklyn, New York, 11220, United States
Northwell Health - North Shore University Hospital
Manhasset, New York, 11030, United States
Northwell Health - Lennox Hill Hospital
New York, New York, 10075, United States
St. Francis
Roslyn, New York, 11576, United States
Good Samaritan University Hospital
West Islip, New York, 11795, United States
University of North Carolina Rex Hospital
Raleigh, North Carolina, 27607, United States
The Ohio State University Medical Center
Columbus, Ohio, 43201, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Seton Medical Center Austin
Austin, Texas, 78705, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Nicosia General Hospital
Nicosia, Cyprus
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
St. Vinzenz Hospital
Cologne, North Rhine-Westphalia, 50733, Germany
Segerberger Kliniken
Bad Segeberg, 23795, Germany
Helios Amper-Klinikum Dachau
Dachau, 85221, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Rheinland Klinikum
Neuss, 41464, Germany
University Medicine Rostock
Rostock, D-18057, Germany
General Hospital of Athens Hippokration
Athens, 11634, Greece
The University General Hospital of Ioannina
Ioannina, 45500, Greece
Thriassion General Hospital
Magoula, 19600, Greece
Shamir Medical Center
Be’er Ya‘aqov, 7030000, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
University Hospital Careggi
Florence, 50134, Italy
University of Messina
Messina, 98124, Italy
Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Skane University Hospital
Lund, 22185, Sweden
Danderyd University Hospital
Stockholm, 18288, Sweden
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE77DN, United Kingdom
Leeds General Infirmary
Leeds, West Yorkshire, LS13EX, United Kingdom
Imperial College Healthcare
London, W120HS, United Kingdom
Related Publications (1)
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.
PMID: 32866927DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Waksman, MD
MedStar Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2019
First Posted
January 9, 2020
Study Start
October 14, 2020
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
September 12, 2025
Record last verified: 2025-09