Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (PCI) Stage I (ILUMIEN I)
- Conditions
- Patients with undergoing percutaneous interventional cardiac procedures for treatment of coronary artery disease
- Registration Number
- JPRN-UMIN000008728
- Lead Sponsor
- St. Jude Medical Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The number and rate of subjects who have any reported MACE at each interval 2.Individual components of MACE at each interval 3.Descriptive statistics on OCT pre and post intervention measurements 4.Relationship between OCT peri-procedural measurements and MACE and each individual components of MACE
- Secondary Outcome Measures
Name Time Method 1.Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment 2.OCT parameters as assessed by Core Lab