Hyperspectral Imaging Pre and Post Endovascular Intervention

NCT00768495 | Unknown

• 1 other identifier: 2008-023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Limb Ischemia; Non-Healing Ulcers

Keywords

revascularization; claudication; hyperspectral; oxygenation; limb ischemia

Study Arms (1)

One Cohort

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HyperMed: lead
• Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA): collaborator

Study Sites (1)

Cardiac, Vascular & Thoracic Surgery Associates

Falls Church, Virginia, 22042, United States

RECRUITING

Related Publications (5)

• 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. doi: 10.1111/j.1532-5415.2007.01123.x.

  PMID: 17397438 BACKGROUND

• White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007 Mar 22;356(12):1241-50. doi: 10.1056/NEJMcp064483. No abstract available.

  PMID: 17377162 BACKGROUND

• Yao ST. Haemodynamic studies in peripheral arterial disease. Br J Surg. 1970 Oct;57(10):761-6. doi: 10.1002/bjs.1800571016. No abstract available.

  PMID: 5476754 BACKGROUND

• Begelman SM, Jaff MR. Noninvasive diagnostic strategies for peripheral arterial disease. Cleve Clin J Med. 2006 Oct;73 Suppl 4:S22-9. doi: 10.3949/ccjm.73.suppl_4.s22.

  PMID: 17385388 BACKGROUND

• 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 BACKGROUND

Related Links

• Sponsor and OxyVu technology website

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Schomacker, PhD

  HyperMed

  STUDY DIRECTOR

Central Study Contacts

Kevin Scomacker, PhD

CONTACT

781-229-5900; kschomacker@hypermed-inc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 4, 2009

Record last verified: 2009-06

Locations

US (1)