Hyperspectral Imaging Pre and Post Endovascular Intervention (CLI-Pre/Post)
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ClinicalTrials.gov Identifier: NCT00768495
Recruitment Status : Unknown
Verified June 2009 by HyperMed. Recruitment status was: Recruiting
First Posted : October 8, 2008
Last Update Posted : June 4, 2009
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
Condition or disease
Chronic Limb IschemiaNon-Healing Ulcers
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.
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Layout table for eligibility information
Ages Eligible for Study:
50 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who have chronic limb ischemia and present with the symptoms of claudication, rest pain or having minor non-healing ulcers or gangrene (Rutherford category 1 to 6) who also require percutaneous endovascular revascularization.
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.
Age group between 50-85
Gender - Male or Female
Race - all race and ethnicities
Patients with known cardiac disease - new MI (within 3 months).
Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing
Patients on supplemental O2 for chronic obstructive lung disease
Bed-ridden subjects - either due to chronic disability or neurological problems