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

  • STATUS
    Recruiting
  • End date
    Aug 11, 2025
  • participants needed
    3100
  • sponsor
    Medstar Health Research Institute
Updated on 11 October 2022
angiography
stenosis
infarction
myocardial infarction
angina pectoris
unstable angina
percutaneous coronary intervention
coronary artery stenosis
stable angina
intravascular ultrasound

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.

Description

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.

Details
Condition Atherosclerosis
Treatment Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Resolute Onyx Drug Eluting Stent
Clinical Study IdentifierNCT04221815
SponsorMedstar Health Research Institute
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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