Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | November 2012 |
End Date: | October 2015 |
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
To define and evaluate OCT stent guidance parameters through prospective data collection in
PCI procedures of de novo lesions.
PCI procedures of de novo lesions.
Inclusion Criteria:
1. Age ≥ 18 years.
2. Patient provides signed written informed consent before any study-specific procedure.
3. De novo coronary artery disease in target vessel.
4. Single or multi vessel disease. For multi vessel disease up to two vessels and three
lesions treated, with no more than two lesions per vessel. Vessel is defined as, left
anterior descending, left circumflex, and right coronary arteries. Any branch within
the vessel is considered part of the vessel.
5. Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and
NSTEMI).
6. Angiographically significant (>50% visual estimation) stenosis present in at least one
native coronary artery.
7. Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects
with an FFR ≤ 0.80 in target vessel.
Exclusion Criteria:
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°) or excessive tortuosity (> two 45° 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.
We found this trial at
16
sites
Emory University Hospital As the largest health care system in Georgia and the only health...
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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