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

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.

Conditions

Atherosclerosis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Atherosclerosis
Intervention / Treatment

-

Contacts and Locations

Tucson

Northwest Medical Center, Tucson, Arizona, United States, 85741

Little Rock

Central Arkansas Veterans Healthcare System, Little Rock, Arkansas, United States, 72205

La Jolla

University of California San Deigo, La Jolla, California, United States, 92037

San Francisco

San Francisco VA Health Care System, San Francisco, California, United States, 94121

Upland

San Antonio Regional Hospital, Upland, California, United States, 91786

Washington

Medstar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Bradenton

Manatee Memorial Hospital, Bradenton, Florida, United States, 34205

Orlando

AdventHealth Orlando, Orlando, Florida, United States, 32803

Pensacola

Ascension Sacred Heart, Pensacola, Florida, United States, 32504

Sebring

AdventHealth Sebring, Sebring, Florida, United States, 33870

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medstar Health Research Institute,

Ronald Waksman, MD, PRINCIPAL_INVESTIGATOR, MedStar Health

Study Record Dates

2027-08