Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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