AtherosclerosisIMPROVENCT04221815
IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
A study testing Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Resolute Onyx Drug Eluting Stent and Onyx Frontier Drug Eluting Stent in people with Atherosclerosis, run by Medstar Health Research Institute at 61 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Resolute Onyx Drug Eluting Stent and Onyx Frontier Drug Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,100 participants
- Where
- 61 sitesin 8 countries
- Study dates
- 14 Oct 2020to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
61 sites in 8 countries.
61 sites in 8 countries
United States40 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Emory
Atlanta, Georgia, 30322
Seton Medical Center Austin
Austin, Texas, 78705
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Northwell Health - South Shore University Hospital
Bay Shore, New York, 11706
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Manatee Memorial Hospital
Bradenton, Florida, 34205
NYU Langone Hospital
Brooklyn, New York, 11220
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, 08103
Rush University Medial Center
Chicago, Illinois, 60612
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735
The Ohio State University Medical Center
Columbus, Ohio, 43201
Ascension St. John
Dearborn, Michigan, 48124
Atlanta VA Medical Center
Decatur, Georgia, 30033
MercyOne Iowa Heart Center
Des Moines, Iowa, 50314
St. Luke's Hospital of Duluth
Duluth, Minnesota, 55805
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Riverside Medical Center
Kankakee, Illinois, 60901
University of California San Deigo
La Jolla, California, 92037
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
Northwell Health - North Shore University Hospital
Manhasset, New York, 11030
University of Minnesota
Minneapolis, Minnesota, 55455
Northwell Health - Lennox Hill Hospital
New York, New York, 10075
AdventHealth Orlando
Orlando, Florida, 32803
Ascension Sacred Heart
Pensacola, Florida, 32504
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240
University of North Carolina Rex Hospital
Raleigh, North Carolina, 27607
Carilion Clinic
Roanoke, Virginia, 24014
St. Francis
Roslyn, New York, 11576
San Francisco VA Health Care System
San Francisco, California, 94121
AdventHealth Sebring
Sebring, Florida, 33870
Baystate Medical Center
Springfield, Massachusetts, 01199
Tampa Cardiovascular/St. Joseph's Hospital
Tampa, Florida, 33614
Northwest Medical Center
Tucson, Arizona, 85741
San Antonio Regional Hospital
Upland, California, 91786
Carle Foundation Hospital
Urbana, Illinois, 61801
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Good Samaritan University Hospital
West Islip, New York, 11795
Germany7 sites
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
Segerberger Kliniken
Bad Segeberg, 23795
St. Vinzenz Hospital
Cologne, North Rhine-Westphalia, 50733
Helios Amper-Klinikum Dachau
Dachau, 85221
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Rheinland Klinikum
Neuss, 41464
University Medicine Rostock
Rostock, D-18057
Greece3 sites
General Hospital of Athens Hippokration
Athens, 11634
The University General Hospital of Ioannina
Ioannina, 45500
Thriassion General Hospital
Magoula, 19600
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Skane University Hospital
Lund, 22185
Danderyd University Hospital
Stockholm, 18288
United Kingdom3 sites
Leeds General Infirmary
Leeds, West Yorkshire, LS13EX
Imperial College Healthcare
London, W120HS
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE77DN
Israel2 sites
Shamir Medical Center
Be’er Ya‘aqov, 7030000
Meir Medical Center
Kfar Saba, 4428164
Italy2 sites
University Hospital Careggi
Florence, 50134
University of Messina
Messina, 98124
About this study
Official title: IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)
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.
Read the detailed 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.
- Conditions
- Atherosclerosis
- Being tested
- Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Resolute Onyx Drug Eluting Stent, Onyx Frontier Drug Eluting Stent, Onyx TruStar Drug Eluting Stent, Onyx TruCor Drug Eluting Stent
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eagle Eye Platinum digital IVUS catheter with optional SyncVisionDevice
IVUS catheter
Resolute Onyx Drug Eluting StentDevice
Stent
Onyx Frontier Drug Eluting StentDevice
Stent
Onyx TruStar Drug Eluting StentDevice
Stent
Onyx TruCor Drug Eluting StentDevice
Stent
| Study group | Role | What they receive |
|---|---|---|
| IVUS guided PCI | Active comparator | Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS Receives: Device: Eagle Eye Platinum digital IVUS catheter with optional SyncVision; Device: Resolute Onyx Drug Eluting Stent; Device: Onyx Frontier Drug Eluting Stent; Device: Onyx TruStar Drug Eluting Stent; Device: Onyx TruCor Drug Eluting Stent |
| Angiographic-guided PCI | Placebo comparator | Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator Receives: Device: Resolute Onyx Drug Eluting Stent; Device: Onyx Frontier Drug Eluting Stent; Device: Onyx TruStar Drug Eluting Stent; Device: Onyx TruCor Drug Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start14 Oct 2020
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221815
- Sponsor's protocol ID
- IMPROVE
- Acronym
- IMPROVE
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32866927
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)
- ClinicalTrials.gov ID
- NCT04221815
- Acronym / sponsor ID
- IMPROVE / IMPROVE
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS guided PCI | Active comparator | Device: Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Device: Resolute Onyx Drug Eluting Stent, Device: Onyx Frontier Drug Eluting Stent, Device: Onyx TruStar Drug Eluting Stent, Device: Onyx TruCor Drug Eluting StentPatients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS |
| Angiographic-guided PCI | Placebo comparator | Device: Resolute Onyx Drug Eluting Stent, Device: Onyx Frontier Drug Eluting Stent, Device: Onyx TruStar Drug Eluting Stent, Device: Onyx TruCor Drug Eluting StentPatients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eagle Eye Platinum digital IVUS catheter with optional SyncVisionIVUS catheter | Device | IVUS guided PCI |
| Resolute Onyx Drug Eluting StentStent | Device | Angiographic-guided PCI, IVUS guided PCI |
| Onyx Frontier Drug Eluting StentStent | Device | Angiographic-guided PCI, IVUS guided PCI |
| Onyx TruStar Drug Eluting StentStent | Device | Angiographic-guided PCI, IVUS guided PCI |
| Onyx TruCor Drug Eluting StentStent | Device | Angiographic-guided PCI, IVUS guided PCI |
Primary outcome
IVUS core lab measures final PCI Minimum Stent Area
Time frame: Intra-procedural
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.
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.
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 32866927Shlofmitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Waksman, MD principal investigator
MedStar Health
61 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Resolute Onyx Drug Eluting Stent and Onyx Frontier Drug Eluting Stent in people with Atherosclerosis, run by Medstar Health Research Institute at 61 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Germany, Greece, Sweden, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IVUS core lab measures final PCI Minimum Stent Area (time frame: Intra-procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.