OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in PCI - ILUMIEN III: OPTIMIZE PCI

St. Jude Medical0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

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•General Inclusion Criteria:
•1) Age >= 18 years.
•2) Patient with an indication for PCI
•3) Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES);Angiographic Inclusion Criteria:
•1) The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of >=2.25 mm to <=3.50 mm.
•2) Total lesion length <40mm

•General Exclusion Criteria:
•1) Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis
•2) STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital
•3) PCI within 24 hours preceding the study procedure
•4) PCI of a lesion within the target vessel within 12 months prior to the study procedure
•5) Planned use of bare metal stent (BMS)
•6) Planned use of bioresorbable vascular scaffold (BVS)
•7) Cardiogenic shock or requiring pressors or hemodynamic support, including IABP, at time of procedure
•8) Mobitz II second degree or complete heart block
•9) Malignant ventricular arrhythmias requiring treatment
•10) Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema
•11) Subject is intubated
•12) Known LVEF <30%
•13) Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
•14) Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA

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