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NCT04221815 · ClinicalTrials.gov registry record · NA
IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
A NA study of Atherosclerosis, sponsored by Medstar Health Research Institute.
- Active
- Registry status
- NA
- Development phase
- 3,100
- Enrollment target
- 20
- Study locations
NCT04221815 is a NA study of Atherosclerosis that is active but no longer recruiting, run by Medstar Health Research Institute. The registered enrollment target is 3,100 participants, above the 1,021-participant average among 69 other Atherosclerosis trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT04221815, a NA study of Atherosclerosis, is active but no longer recruiting, sponsored by Medstar Health Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 3,100 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 3,100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,021-participant average among 69 other Atherosclerosis trials with a reported enrollment target (204% higher). The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
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.
NCT04221815 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Georgia.
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.
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).
Who is sponsoring clinical trial NCT04221815?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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