Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I) - Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I)

St. Jude Medical Japan Co., Ltd.0 个研究点目标入组 500 人开始时间: 2012年8月20日最近更新: 2023年10月17日

适应症

试验速览

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•1.Subjects with STEMI, emergent PCI, or in cardiogenic shock. 2.Subjects with target left main lesion. 3.Subjects with restenosis or stent thrombosis in the target vessel. 4.Planned use of bare metal stent. 5.Known renal insufficiency (examples being but not limited to eGFR < 60 ml/kg/m2, serum creatinine >= 2.5 mg/dL, or on dialysis). 6.Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). 7.Extreme angulation (> 90 degree) or excessive tortuosity (> two 45 degree angles) proximal to or within the target lesion. 8.Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease. 9.Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results. 10.Currently participating in another clinical study that interferes with study results. 11.Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. 12.Life expectancy less than 1 year. 13.Potential for non-compliance to protocol requirements and follow-up. 14.Planned or prior heart transplantation or listed for heart transplant. 15.Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.

发起方

St. Jude Medical Japan Co., Ltd.