Hyperspectral Imaging Pre and Post Endovascular Intervention

• Conditions: Chronic Limb Ischemia; Non-Healing Ulcers

• Registration Number: NCT00768495
• Lead Sponsor: HyperMed

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-04
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Cardiac, Vascular & Thoracic Surgery Associates; 🇺🇸 Falls Church, Virginia, United States