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

Completed

Conditions: Coronary Artery Disease - Disease of the heart vessels
10011082

Registration Number: NL-OMON37156

Lead Sponsor: St. Jude Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1. Age >= 18 years
2. Patient provides signed written informed consent before any studyspecific procedure
3. De novo coronary artery disease in target vessel
4. Single of 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 in considered part of the vessel.
5. Elective or ad hoc PCI, stabe angina, acute coronary syndrome (unstable angina and NSTEMI)
6. Angiographically significant (>50% visiual 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. Plannen use of bare metal stent
5. Known renal insufficiency (examples being but not limited to eGFR<60ml/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. Extrene angulation (>90%) or excessive tortuosity (>45degree angles) proximal to or within the target lesion
8. Vessel(s) and lesion(s) non amenable for PC, for examples diffuse disease
9. Anu other medical condition that in the opinion of the investigator will interfere with patient safety or study results

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Identify OCT peri-procedural guidance parameter(s) for stent implantation that<br /><br>relates with patient outcomes in the hospital, at 30 days, and 12 months post<br /><br>intervention.<br /><br><br /><br>(No formal hypothesis will be tested as this is an observational study.)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assessment of impact of OCT on physician decision-making pre and post PCI.<br /><br>- Correlation/relationship of OCT parameters, as defined by OCT volumetric<br /><br>analysis, on pre and post intervention FFR values.<br /><br>- Consideration of health economics data and resource utilization<br /><br><br /><br><br /><br>(No formal hypothesis will be tested as this is an observational study.)</p><br>