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

NCT04221815 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3100

Last updated 2025-09-12

No results posted yet for this 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

Interventions

DEVICE

Eagle Eye Platinum digital IVUS catheter with optional SyncVision

IVUS catheter

DEVICE

Resolute Onyx Drug Eluting Stent

Stent

DEVICE

Onyx Frontier Drug Eluting Stent

Stent

DEVICE

Onyx TruStar Drug Eluting Stent

Stent

DEVICE

Onyx TruCor Drug Eluting Stent

Stent

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Ron Waksman, MD · MedStar Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States
  • Cyprus
  • Germany
  • Greece
  • Israel
  • Italy
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221815 on ClinicalTrials.gov