Status:
COMPLETED
Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
Lead Sponsor:
North Texas Veterans Healthcare System
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
PERIPHERAL VASCULAR DISEASE
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Despite recent advances in stent technology and its widespread application in the treatment of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent lumen (in-stent re...
Detailed Description
The pre-recruitment process would identify diabetics who have life-style limiting claudication in their legs. Based on the physicians decision such patients may have to undergo a peripheral vascular i...
Eligibility Criteria
Inclusion
- Diabetics, insulin or non-insulin dependent above 21 years of age
- Able to provide an informed consent
- Life expectancy \> 1 year
- Presenting with with moderate claudication (Rutherford stage 2), severe intermittent claudication (Rutherford stage 3), chronic critical limb ischemia with pain while the patient was at rest(Rutherford stage 4), or chronic critical limb ischemia with ischemic ulcers/gangrene(Rutherford stage 5/6)
- Placement of \> 5 mm in diameter self-expanding Nitinol stent in the SFA, with at least 1 vessel infra-popliteal runoff
- Placement of \> 60 mm in length self-expanding Nitinol stent in the SFA, with at least 1 vessel infra-popliteal runoff
Exclusion
- Serum creatinine of \>= 2.0 mg/dl
- Presence of iodinated contrast allergy
- Presence of allergy to Aspirin and Plavix
- Pregnancy
- Relative or absolute contraindication for anticoagulation
- History of allergy to Angiomax and unfractionated heparin or heparin induced thrombocytopenia (HIT)
- White blood count \< 3000; platelet count \< 100000, and baseline hemoglobin \< 10 g/dl
- Absence of brisk at least 1 vessel infra-popliteal runoff to the foot
- Left ventricular ejection fraction \< 25%
- Relative or absolute contraindication for anticoagulation
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00827853
Start Date
November 1 2008
End Date
February 1 2012
Last Update
November 4 2013
Active Locations (4)
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1
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
2
VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
3
Dallas Veterans Hospital
Dallas, Texas, United States, 75216
4
Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231