CLI-Pre/Post: Hyperspectral Imaging Pre and Post Endovascular Intervention

Sponsor

HyperMed (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00768495

Collaborator

Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA) (Other)

Enrollment

Location

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Limb Ischemia Non-Healing Ulcers

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
One Cohort

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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