Hyperspectral Imaging Pre and Post Endovascular Intervention (CLI-Pre/Post)

HyperMed Imaging

Status: Unknown

Conditions: Non-Healing Ulcers; Chronic Limb Ischemia

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT00768495

2008-023

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

One Cohort