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IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
NCT04221815 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE Eagle Eye Platinum digital IVUS catheter with optional SyncVision
- DEVICE Resolute Onyx Drug Eluting Stent
- DEVICE Onyx Frontier Drug Eluting Stent
- DEVICE Onyx TruStar Drug Eluting Stent
- DEVICE Onyx TruCor Drug Eluting Stent
Study Locations (20)
Florida
- Manatee Memorial Hospital — Bradenton
- AdventHealth Orlando — Orlando
- Ascension Sacred Heart — Pensacola
- AdventHealth Sebring — Sebring
- Tampa Cardiovascular/St. Joseph's Hospital — Tampa
California
- University of California San Deigo — La Jolla
- San Francisco VA Health Care System — San Francisco
- San Antonio Regional Hospital — Upland
Georgia
- Emory — Atlanta
- Atlanta VA Medical Center — Decatur
- Northeast Georgia Medical Center — Gainesville
Illinois
- Rush University Medial Center — Chicago
- Riverside Medical Center — Kankakee
- Carle Foundation Hospital — Urbana
Maryland
- MedStar Union Memorial Hospital — Baltimore
- MedStar Southern Maryland Hospital Center — Clinton
Arizona
- Northwest Medical Center — Tucson
Arkansas
- Central Arkansas Veterans Healthcare System — Little Rock
District of Columbia
- Medstar Washington Hospital Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,100 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2027-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04221815
The ClinicalTrials.gov registry entry for NCT04221815 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 130 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atherosclerosis appearing as the primary indexed condition, and to 5 interventions — of which Eagle Eye Platinum digital IVUS catheter with optional SyncVision is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04221815 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04221815 about?
NCT04221815 is a clinical study titled "IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact". 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 ...
What is the current status of trial NCT04221815?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 3,100 participants. The study started on 2020-10-14. Estimated completion is 2027-09.
What conditions does trial NCT04221815 study?
This clinical trial studies the following conditions: Atherosclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04221815?
The interventions under investigation include: Eagle Eye Platinum digital IVUS catheter with optional SyncVision (DEVICE), Resolute Onyx Drug Eluting Stent (DEVICE), Onyx Frontier Drug Eluting Stent (DEVICE), Onyx TruStar Drug Eluting Stent (DEVICE), Onyx TruCor Drug Eluting Stent (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04221815?
This trial is sponsored by Medstar Health Research Institute, which has 130 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04221815 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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