Clinical trial NCT00768495: Hyperspectral Imaging Pre and Post Endovascular Intervention
Official 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).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Limb Ischemia
Non-Healing Ulcers
Keywords: revascularization
claudication
hyperspectral
oxygenation
limb ischemia
Lead sponsor: HyperMed
Sponsor class: INDUSTRY
Collaborators: name: Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
First posted: 2008-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Cardiac, Vascular & Thoracic Surgery Associates
state: Virginia
Study officials:
affiliation: HyperMed
name: Kevin Schomacker, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1111/j.1532-5415.2007.01123.x.
citation: White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007 Mar 22;356(12):1241-50. doi: 10.1056/NEJMcp064483. No abstract available.
citation: Yao ST. Haemodynamic studies in peripheral arterial disease. Br J Surg. 1970 Oct;57(10):761-6. doi: 10.1002/bjs.1800571016. No abstract available.
citation: Begelman SM, Jaff MR. Noninvasive diagnostic strategies for peripheral arterial disease. Cleve Clin J Med. 2006 Oct;73 Suppl 4:S22-9. doi: 10.3949/ccjm.73.suppl_4.s22.
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.