Status:
UNKNOWN
Hyperspectral Imaging Pre and Post Endovascular Intervention
Lead Sponsor:
HyperMed
Collaborating Sponsors:
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
Conditions:
Chronic Limb Ischemia
Non-Healing Ulcers
Eligibility:
All Genders
50-85 years
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 art...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00768495
Start Date
October 1 2008
End Date
December 1 2009
Last Update
June 4 2009
Active Locations (1)
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1
Cardiac, Vascular & Thoracic Surgery Associates
Falls Church, Virginia, United States, 22042