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

August 21, 2023 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

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 Contact

Study Locations

  • Germany
      • Berlin, Germany, 12559
        • Withdrawn
        • DRK Kliniken Berlin Köpenik
      • Dachau, Germany, 85221
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
        • Principal Investigator:
          • Moritz Seiffert, MD
    • NRW
      • Bad Oeynhausen, NRW, Germany, 32545
        • Recruiting
        • Herz-und Diabeteszentrum NRW
        • Contact:
        • Principal Investigator:
          • Werner Scholtz
    • North Rhine Westphalia
      • Cologne, North Rhine Westphalia, Germany, 50733
  • Italy
      • Messina, Italy, 98124
  • Sweden
      • Gothenburg, Sweden, 41345
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Sebastian Völz
      • Lund, Sweden, 22185
        • Recruiting
        • Skåne University Hospital
        • Contact:
        • Principal Investigator:
          • David Erlinge, MD
      • Stockholm, Sweden, 18288
  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS13EX
        • Recruiting
        • Leeds General Infirmary
        • Contact:
        • Principal Investigator:
          • Abdul Mozid
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Northwest Medical Center
        • Contact:
        • Principal Investigator:
          • Dexter Deleon
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Deigo
        • Contact:
        • Principal Investigator:
          • Ehtisham Mahmud, MD
      • San Francisco, California, United States, 94121
        • Recruiting
        • San Francisco VA Health Care System
        • Contact:
        • Principal Investigator:
          • Jeffrey Zimmet
      • Upland, California, United States, 91786
        • Recruiting
        • San Antonio Regional Hospital
        • Contact:
        • Principal Investigator:
          • Suraj Rasani, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Principal Investigator:
          • Itsik Ben-Dor, MD
        • Contact:
    • Florida
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Manatee Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Santosh Mathews, MD
      • Orlando, Florida, United States, 32803
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Ascension Sacred Heart
        • Contact:
        • Principal Investigator:
          • Rohit Amin, MD
      • Sebring, Florida, United States, 33870
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Tampa Cardiovascular/St. Joseph's Hospital
        • Contact:
        • Principal Investigator:
          • Saihari Sadanandan, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory
        • Contact:
        • Principal Investigator:
          • Wissam A Jaber, MD
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Contact:
        • Principal Investigator:
          • Gautum Kumar, MD
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Northeast Georgia Medical Center
        • Contact:
        • Principal Investigator:
          • Habib Samady, MD
    • Illinois
      • Kankakee, Illinois, United States, 60901
        • Recruiting
        • Riverside Medical Center
        • Contact:
        • Principal Investigator:
          • Vikas K Patel, MD
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Foundation Hospital
        • Contact:
        • Principal Investigator:
          • Issam Moussa, MD
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Terminated
        • MercyOne Iowa Heart Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • MedStar Union Memorial Hospital
        • Contact:
        • Principal Investigator:
          • John Wang
      • Clinton, Maryland, United States, 20735
        • Recruiting
        • MedStar Southern Maryland Hospital Center
        • Contact:
        • Principal Investigator:
          • Brian Case
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Springfield, Massachusetts, United States, 01199
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Recruiting
        • Ascension St. John
        • Principal Investigator:
          • Amir Kaki
        • Contact:
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • St. Luke's Hospital of Duluth
        • Contact:
        • Principal Investigator:
          • Scott Mikesell, DO
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Ganesh Raveendran, MD
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Virtua Our Lady of Lourdes Hospital
        • Contact:
        • Principal Investigator:
          • Luai Tabaza, MD
      • Pomona, New Jersey, United States, 08240
        • Recruiting
        • AtlantiCare Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Burak M Arkonac, MD
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Northwell Health - South Shore University Hospital
        • Contact:
        • Principal Investigator:
          • Luis Gruberg, MD
      • Brooklyn, New York, United States, 11220
      • Manhasset, New York, United States, 11030
        • Recruiting
        • NorthWell Health - North Shore University Hospital
        • Contact:
        • Principal Investigator:
          • Luis Gruberg, MD
      • New York, New York, United States, 10075
        • Recruiting
        • NorthWell Health - Lennox Hill Hospital
        • Contact:
        • Principal Investigator:
          • Luis Gruberg, MD
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis
        • Contact:
        • Principal Investigator:
          • Evan Shlofmitz, DO
      • Syracuse, New York, United States, 13210
        • Withdrawn
        • SUNY Upstate Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • University of North Carolina Rex Hospital
        • Contact:
        • Principal Investigator:
          • Willis Wu, MD
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Recruiting
        • The Ohio State University Medical Center
        • Contact:
        • Principal Investigator:
          • Raymond D Magorien, MD
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital
        • Contact:
        • Principal Investigator:
          • Shailendra Singh, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Seton Medical Center Austin
        • Contact:
        • Principal Investigator:
          • Mark Gajjar, MD
      • El Paso, Texas, United States, 79905
        • Recruiting
        • Texas Tech University Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Manu Rajachandran, MD
    • Virginia
      • Roanoke, Virginia, United States, 24014

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 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
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

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

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)

April 1, 2024

Study Completion (Estimated)

August 1, 2025

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 (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

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 Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe