Falls Church, Virginia 22042


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT00768495


Primary Contact:

Study Director
Kevin Schomacker, PhD
HyperMed, Inc

Kevin Scomacker, PhD
Phone: 781-229-5900
Email: kschomacker@hypermed-inc.com


Backup Contact:

N/A


Location Contact:

Falls Church, Virginia 22042
United States

Dipankar Mukherjee, MD
Phone: 703-280-5858

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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