An interventional study of Eagle Eye Platinum digital IVUS catheter with optional SyncVision and Resolute Onyx Drug Eluting Stent in Atherosclerosis, sponsored by Medstar Health Research Institute. Active, not recruiting at 61 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
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.
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.
1,567 studies on the registry are indexed under Atherosclerosis; 265 are open to participants now.
This study's planned enrollment of 3,100 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive a pre-PCI IVUS, IVUS guided stent sizing and optimization per study protocol, post-PCI IVUS
Device: Eagle Eye Platinum digital IVUS catheter with optional SyncVision · Device: Resolute Onyx Drug Eluting Stent · Device: Onyx Frontier Drug Eluting Stent · Device: Onyx TruStar Drug Eluting Stent · Device: Onyx TruCor Drug Eluting Stent
Patients will receive angiography guided PCI and angiographic optimization per local standard practice, as well as a post-PCI IVUS blinded to the investigator
Device: Resolute Onyx Drug Eluting Stent · Device: Onyx Frontier Drug Eluting Stent · Device: Onyx TruStar Drug Eluting Stent · Device: Onyx TruCor Drug Eluting Stent
IVUS catheter
Stent
Stent
Stent
Stent
IVUS core lab measures final PCI Minimum Stent Area
The imaging primary endpoint is the final post-PCI minimum stent area (MSA) assessed by IVUS in each randomized arm, measured at an independent IVUS core laboratory blinded to treatment assignment. The MSA is an appropriate co-primary imaging endpoint as it is the most consistent and strongest parameter to predict clinical outcomes.11-14 In the present study, after 2,000 subjects are enrolled with the procedure completed, the primary endpoint of MSA will be tested to compare the IVUS-guided and angiography-guided arms. If significantly larger MSA in the IVUS-guided arm is demonstrated, the trial will continue enrolling subjects.
Time frame: Intra-procedural
Target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related-myocardial infarction (MI), and ischemia-driven target vessel revascularization.
The clinical primary endpoint is target vessel failure (TVF) outcomes at 12 months defined as the composite of cardiac death, target vessel related- myocardial infarction (MI), and target vessel revascularization.
Time frame: 12 months
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Medstar Health Research Institute