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

Atherosclerosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04221815
Study type Interventional
Source Medstar Health Research Institute
Contact Shreejana Pokharel
Phone 2409417922
Email shreejana.pokharel@medstar.net
Status Recruiting
Phase N/A
Start date October 14, 2020
Completion date August 2027
View Details
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