Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)

Details

This is a prospective, single-blind clinical investigation randomizing subjects to IVUS-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 120 centers in the US, Canada, and Europe. Approximately 2,500-3,100 randomized subjects and up to 3 roll-in subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 2 years. The expected duration of enrollment is approximately 2.5 years. The total duration of the clinical investigation is expected to be approximately 4.5 years.

Keywords

Atherosclerosis Eagle Eye Platinum digital IVUS catheter with optional SyncVision Resolute Onyx Drug Eluting Stent IVUS guided PCI Angiographic-guided PCI

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join if...

  • Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock
  • Use of fibrinolytic therapy within 24 hours of PCI
  • Planned revascularization as a staged procedure
  • Stent thrombosis
  • Use of optical coherence tomography (OCT) during the index procedure

Locations

  • University of California San Deigo accepting new patients
    La Jolla California 92037 United States
  • San Antonio Regional Hospital accepting new patients
    Upland California 91786 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medstar Health Research Institute
ID
NCT04221815
Study Type
Interventional
Participants
Expecting 3100 study participants
Last Updated