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

Running, not enrolling · Not applicable

Conditions studied: Atherosclerosis

In brief

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.

Key facts

Study ID

NCT04221815

Run by

Medstar Health Research Institute

People needed

3100

Starts

2020-10-14

Expected to finish

2027-09-01

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• University of California San Deigo — La Jolla, California, United States
• San Francisco VA Health Care System — San Francisco, California, United States
• San Antonio Regional Hospital — Upland, California, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Ascension Sacred Heart — Pensacola, Florida, United States
• AdventHealth Sebring — Sebring, Florida, United States
• Tampa Cardiovascular/St. Joseph's Hospital — Tampa, Florida, United States
• Emory — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Rush University Medial Center — Chicago, Illinois, United States
• Riverside Medical Center — Kankakee, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• MercyOne Iowa Heart Center — Des Moines, Iowa, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• MedStar Southern Maryland Hospital Center — Clinton, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Ascension St. John — Dearborn, Michigan, United States
• St. Luke's Hospital of Duluth — Duluth, Minnesota, United States
• Northwest Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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