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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.

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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

FieldValue
Enrollment Target 3,100 participants
Start Date 2020-10-14
Est. Completion 2027-09
Phase NA

Sponsor

Medstar Health Research Institute

115 total trials

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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.