NCT04221815

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,100 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-14
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2020-01-09
• Last updated: 2025-09-12

Locations

61 sites across 8 countries: United States, Cyprus, Germany, Greece, Israel, Italy, Sweden, United Kingdom

Regulatory

• FDA-regulated device study