Hyperspectral Imaging Pre and Post Endovascular Intervention



Status:Completed
Conditions:Peripheral Vascular Disease, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:50 - 85
Updated:4/2/2016
Start Date:October 2008
End Date:December 2009
Contact:Kevin Scomacker, PhD
Email:kschomacker@hypermed-inc.com
Phone:781-229-5900

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Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).

This trial will collect tissue oxygenation data via hyperspectral imaging before and after
endovascular procedures.

This will be a nonrandomized, nonblinded, prospective observational study to correlate the
results obtained with the traditional measures of success of endovascular revascularization
of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with
oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging
device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.

Inclusion Criteria:

1. Patients with established diagnosis of lower limb ischemic based on their symptoms of
claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory
tests that are currently used to make this diagnosis and have been scheduled for
endovascular revascularization.

2. Age group between 50-85

3. Gender - Male or Female

4. Race - all race and ethnicities

Exclusion Criteria:

1. Patients with known cardiac disease - new MI (within 3 months).

2. Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day
of testing

3. Patients on supplemental O2 for chronic obstructive lung disease

4. Bed-ridden subjects - either due to chronic disability or neurological problems
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Falls Church, VA
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