Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease

Completed · Not applicable

Conditions studied: PERIPHERAL VASCULAR DISEASE

In brief

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 restenosis) due to in growth of cells (neo-intimal proliferation) is unacceptably high. In diabetics with long superficial femoral artery (SFA) lesions, in-stent restenosis rates are higher than in non-diabetics. Consequently interventional techniques that curtail in-stent restenosis have to be explored. Cryoplasty is a stent expansion method in which a balloon is expanded using pressurized nitrous oxide gas. As the nitrous oxide expands in the balloon it cools the surroundings to about -10 degrees C. This induces programed death (apoptosis) of the smooth muscle cells in arterial wall. The investigators hypothesize that Cryoplasty, by inducing an apoptotic smooth muscle cell response, when applied to post-dilation of nitinol self-expanding stents in the Superficial Femoral Artery (SFA) of diabetics, would lead to decreased in-stent restenosis due to decreased neointimal proliferation.

Key facts

Study ID

NCT00827853

Run by

North Texas Veterans Healthcare System

People needed

90

Starts

2008-11-01

Expected to finish

2012-02-01

Last updated by the study team

2013-11-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• VA Medical Center — Oklahoma City, Oklahoma, United States
• Dallas Veterans Hospital — Dallas, Texas, United States
• Dallas Presbyterian Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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