Non-invasive Computer-Aided Phenotyping of Vasculopathy

The investigators hypothesize that in vivo MRI and/or CT examinations of patients, when
suitably acquired and analyzed with the vascuCAP™ analysis software, can provide a
sufficiently accurate profile of plaque characteristics to provide an objective basis for
patient management. Study subjects include patients undergoing endarterectomies to mitigate
their clinical risk or symptoms for conditions including stroke, claudication, and critical
limb ischemia. The endarterectomy specimens removed at surgery will allow a direct comparison
between the MRI information obtained prior to the surgery and the histopathological analyses
of the arterial specimens. The vascuCAP™ measurements of structural and functional features
of the arterial wall will be performed in patients undergoing endarterectomy. Measured
results will be compared in a blinded fashion with histology to assess performance of plaque
profiling and build a pilot prediction model for risk scoring.

Inclusion Criteria:

Individuals must meet one of the following inclusion criteria in order to be eligible to
participate in the study:

- Case subjects will be patients with documented carotid atherosclerosis, scheduled for
magnetic resonance or CT angiography and subsequent elective endarterectomy with 30
days of enrollment in the study

- Case subjects will be patients with peripheral arterial disease (PAD) with clinical
symptoms, scheduled for magnetic resonance or CT angiography and indicated
endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in
the study

Exclusion Criteria:

- Subjects with claustrophobia or inability to tolerate prior MRI studies.

- Subjects with metal implants that are not MRI compatible (LSU detailed checklist to be
attached) including: Subjects with any type of bio-implant activated by mechanical,
electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators,
biostimulators, electronic infusion pumps, etc.). Subjects with any type of
ferromagnetic bio-implant that could potentially be displaced or damaged, such as
aneurysm clips, metallic skull plates, etc.

- Subjects with a history of kidney disease or dialysis that are unable to receive
intravenous gadolinium contrast material.

- Female subjects. A urine pregnancy test will be required of all female subjects of
childbearing potential prior to inclusion in this study. Pregnant or nursing females
will be excluded from the study.

- Subjects who cannot adhere to the experimental protocol.

- Subjects allergic to contrast material.