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

Condition(s) studied

Investigational drug(s) / intervention(s)

Eagle Eye Platinum digital IVUS catheter with optional SyncVision: IVUS catheter

Resolute Onyx Drug Eluting Stent: Stent

Onyx Frontier Drug Eluting Stent: Stent

Onyx TruStar Drug Eluting Stent: Stent

Onyx TruCor Drug Eluting Stent: Stent

Study 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.

Eligibility

Primary outcome measure(s)

• IVUS core lab measures final PCI Minimum Stent Area — Intra-procedural
  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.
• 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. — 12 months
  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.

Trial sites (61)

+ 21 more sites — see the full list on the official registry below.

Other trials for the same condition