Falls Church, Virginia 22042


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

2008-023


NCT ID:

NCT00768495


Secondary ID:


Study Acronym:

CLI-Pre/Post


Brief Title:

Hyperspectral Imaging Pre and Post Endovascular Intervention


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).


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

50 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

HyperMed, Inc


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kevin Schomacker, PhD
Study Director
HyperMed, Inc
Primary Contact:Kevin Scomacker, PhD
781-229-5900
kschomacker@hypermed-inc.com

Study Dates

Start Date:October 2008
Completion Date:December 2009
Completion Type:Anticipated
Primary Completion Date:December 2009
Primary Completion Type:Anticipated
Verification Date:June 2009
Last Changed Date:June 2, 2009
First Received Date:October 6, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:One Cohort

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:HyperMed, Inc
Agency Class:Other
Agency Type:Collaborator
Agency Name:Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Ostchega Y, Paulose-Ram R, Dillon CF, Gu Q, Hughes JP. Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey 1999-2004. J Am Geriatr Soc. 2007 Apr;55(4):583-9.
PMID:17397438
Reference Type:Reference
Citation:White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007 Mar 22;356(12):1241-50. Review. No abstract available.
PMID:17377162
Reference Type:Reference
Citation:Yao ST. Haemodynamic studies in peripheral arterial disease. Br J Surg. 1970 Oct;57(10):761-6. No abstract available.
PMID:5476754
Reference Type:Reference
Citation:Begelman SM, Jaff MR. Noninvasive diagnostic strategies for peripheral arterial disease. Cleve Clin J Med. 2006 Oct;73 Suppl 4:S22-9. Review.
PMID:17385388
Reference Type:Reference
Citation:Raines JK, Darling RC, Buth J, Brewster DC, Austen WG. Vascular laboratory criteria for the management of peripheral vascular disease of the lower extremities. Surgery. 1976 Jan;79(1):21-9.
PMID:1246689

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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