Hyperspectral Imaging Pre and Post Endovascular Intervention

Chronic Limb Ischemia Clinical Trial

— CLI-Pre/Post  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00768495
• Other study ID #: 2008-023
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2008
• Last updated: June 2, 2009
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: HyperMed
• Contact: Kevin Scomacker, PhD
• Phone: 781-229-5900
• Email: kschomacker[@]hypermed-inc.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Limb Ischemia
• Ischemia
• Non-Healing Ulcers

Locations

Country	Name	City	State
United States	Cardiac, Vascular & Thoracic Surgery Associates	Falls Church	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
HyperMed	Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

External Links

•   Sponsor and OxyVu technology website