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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by HyperMed, Inc.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
Information provided by:
HyperMed, Inc
ClinicalTrials.gov Identifier:
NCT00768495
First received: October 6, 2008
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

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


Condition
Chronic Limb Ischemia
Non-Healing Ulcers

Study Type: Observational
Study Design: 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).

Further study details as provided by HyperMed, Inc:

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
One Cohort

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768495

Contacts
Contact: Kevin Scomacker, PhD 781-229-5900 kschomacker@hypermed-inc.com

Locations
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
HyperMed, Inc
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
Investigators
Study Director: Kevin Schomacker, PhD HyperMed, Inc