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

September 8, 2025 updated by: Medstar Health Research Institute

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

3100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Nicosia General Hospital
  • Germany
      • Bad Segeberg, Germany, 23795
        • Segerberger Kliniken
      • Dachau, Germany, 85221
        • Helios Amper-Klinikum Dachau
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf
      • Neuss, Germany, 41464
        • Rheinland Klinikum
      • Rostock, Germany, D-18057
        • University Medicine Rostock
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Herz-und Diabeteszentrum NRW
      • Cologne, North Rhine-Westphalia, Germany, 50733
        • St. Vinzenz Hospital
  • Greece
      • Athens, Greece, 11634
        • General Hospital of Athens Hippokration
      • Ioannina, Greece, 45500
        • The University General Hospital of Ioannina
      • Magoula, Greece, 19600
        • Thriassion General Hospital
  • Israel
      • Be’er Ya‘aqov, Israel, 7030000
        • Shamir Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
  • Italy
      • Florence, Italy, 50134
        • University Hospital Careggi
      • Messina, Italy, 98124
        • University of Messina
  • Sweden
      • Gothenburg, Sweden, 41345
        • Sahlgrenska University Hospital
      • Lund, Sweden, 22185
        • Skåne University Hospital
      • Stockholm, Sweden, 18288
        • Danderyd University Hospital
  • United Kingdom
      • London, United Kingdom, W120HS
        • Imperial College Healthcare
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE77DN
        • Freeman Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS13EX
        • Leeds General Infirmary
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Northwest Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Healthcare System
    • California
      • La Jolla, California, United States, 92037
        • University of California San Deigo
      • San Francisco, California, United States, 94121
        • San Francisco VA Health Care System
      • Upland, California, United States, 91786
        • San Antonio Regional Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Bradenton, Florida, United States, 34205
        • Manatee Memorial Hospital
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Pensacola, Florida, United States, 32504
        • Ascension Sacred Heart
      • Sebring, Florida, United States, 33870
        • Adventhealth Sebring
      • Tampa, Florida, United States, 33614
        • Tampa Cardiovascular/St. Joseph's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medial Center
      • Kankakee, Illinois, United States, 60901
        • Riverside Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • MercyOne Iowa Heart Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • MedStar Union Memorial Hospital
      • Clinton, Maryland, United States, 20735
        • MedStar Southern Maryland Hospital Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Ascension St. John
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital of Duluth
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Virtua Our Lady of Lourdes Hospital
      • Pomona, New Jersey, United States, 08240
        • AtlantiCare Regional Medical Center
    • New York
      • Bay Shore, New York, United States, 11706
        • Northwell Health - South Shore University Hospital
      • Brooklyn, New York, United States, 11220
        • NYU Langone Hospital
      • Manhasset, New York, United States, 11030
        • NorthWell Health - North Shore University Hospital
      • New York, New York, United States, 10075
        • NorthWell Health - Lennox Hill Hospital
      • Roslyn, New York, United States, 11576
        • St. Francis
      • West Islip, New York, United States, 11795
        • Good Samaritan University Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • University of North Carolina Rex Hospital
    • Ohio
      • Columbus, Ohio, United States, 43201
        • The Ohio State University Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center Austin
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IVUS guided PCI
Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS
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
Placebo Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

  • Principal Investigator: Ron Waksman, MD, MedStar Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 27, 2019

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPROVE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerosis

Clinical Trials on Eagle Eye Platinum digital IVUS catheter with optional SyncVision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe