ACTIVE_NOT_RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-10-14
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04221815

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years at screening
  2. * PCI with stent implantation involving a high risk or complex lesion defined as involving at least one of the following characteristics:
  3. * Chronic total occlusion
  4. * In-stent restenosis
  5. * Severe coronary artery calcification
  6. * Long lesion (≥ 28 mm in length)
  7. * Bifurcation lesion (Any Medina class that involves main branch disease with a side branch ≥2.0 mm)
  8. * Stable angina, unstable angina, or non-ST Elevation myocardial infarction (NSTEMI), undergoing PCI of a single or multivessel coronary artery stenosis
  9. * PCI performed with either angiography alone, or IVUS guidance used
  1. * Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock
  2. * Use of fibrinolytic therapy within 24 hours of PCI
  3. * Planned revascularization of a target vessel as a staged procedure
  4. * Stent thrombosis
  5. * Use of optical coherence tomography (OCT) during the index procedure

Contacts and Locations

Principal Investigator

Ron Waksman, MD
PRINCIPAL_INVESTIGATOR
MedStar Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

  • Ron Waksman, MD, PRINCIPAL_INVESTIGATOR, MedStar Health

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 Registration Dates

Study Start Date2020-10-14
Study Completion Date2027-09

Study Record Updates

Study Start Date2020-10-14
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Atherosclerosis