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IMPact on Revascularization Outcomes of intraVascular ultrasound guided treatment of complex lesions and Economic impact (IMPROVE)

Recruiting

To compare the outcomes of patients with complex lesions treated with imaging guidance with IVUS versus angiography only.

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All
18 Years to old
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 as a staged procedure Stent thrombosis Use of optical coherence tomography (OCT) during the index procedure

Device: Eagle Eye Platinum digital IVUS catheter with optional SyncVision, Device: Resolute Onyx Drug Eluting Stent

Atherosclerosis

Clinics and Surgery Center (CSC)

Julie Longman - longm021@umn.edu
Ganesh Raveendran
N/A
STUDY00014771
STUDY00014771
See this study on ClinicalTrials.gov

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