Chronic Limb Ischemia Clinical Trial
— CLI-Pre/PostOfficial title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 85 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Cardiac, Vascular & Thoracic Surgery Associates | Falls Church | Virginia |
Lead Sponsor | Collaborator |
---|---|
HyperMed | Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA) |
United States,
Begelman SM, Jaff MR. Noninvasive diagnostic strategies for peripheral arterial disease. Cleve Clin J Med. 2006 Oct;73 Suppl 4:S22-9. Review. — View Citation
Ostchega Y, Paulose-Ram R, Dillon CF, Gu Q, Hughes JP. Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey 1999-2004. J Am Geriatr Soc. 2007 Apr;55(4):583-9. — View Citation
Raines JK, Darling RC, Buth J, Brewster DC, Austen WG. Vascular laboratory criteria for the management of peripheral vascular disease of the lower extremities. Surgery. 1976 Jan;79(1):21-9. — View Citation
White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007 Mar 22;356(12):1241-50. Review. — View Citation
Yao ST. Haemodynamic studies in peripheral arterial disease. Br J Surg. 1970 Oct;57(10):761-6. — View Citation
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