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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768495
Recruitment Status : Unknown
Verified June 2009 by HyperMed.
Recruitment status was:  Recruiting
First Posted : October 8, 2008
Last Update Posted : June 4, 2009
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
Information provided by:

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

Condition or disease
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 Type : Observational
Estimated 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 : October 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

One Cohort

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have chronic limb ischemia and present with the symptoms of claudication, rest pain or having minor non-healing ulcers or gangrene (Rutherford category 1 to 6) who also require percutaneous endovascular revascularization.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768495

Contact: Kevin Scomacker, PhD 781-229-5900

United States, Virginia
Cardiac, Vascular & Thoracic Surgery Associates Recruiting
Falls Church, Virginia, United States, 22042
Contact: Dipankar Mukherjee, MD    703-280-5858 ext 1111      
Sponsors and Collaborators
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
Study Director: Kevin Schomacker, PhD HyperMed