Overview
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.
Eligibility
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 of a target vessel as a staged procedure
- Stent thrombosis
- Use of optical coherence tomography (OCT) during the index procedure