Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)

This is an interventional health services research trial for Peripheral Arterial Disease focused on measuring Endovascular Intervention, MRI, Ultrasound, Cholesterol Medications, High Cholesterol, Peripheral Arterial disease, Claudication, Leg Pain, Niaspan, Extended Release Niacin, Zetia, Ezetimibe, Simvastatin, Zocor, Atorvastatin, Lipitor Read More

Inclusion Criteria:

• Symptoms consistent with calf claudication and described as life style limiting
• Objective evidence of peripheral artery disease (PAD): Ankle brachial index less than 0.9 OR other hemodynamic or imaging modalities confirming significant PAD
• Baseline imaging reveals superficial femoral artery (SFA) disease starting at least 5 cm from the origin of the SFA
• Agrees to be available for follow-up and is able to participate in all study testing procedures
• Weight and/or body characteristics that will allow testing with MRI
• No known contraindication to lipid lowering agents
• Serum creatinine level less than 2.5 mg/dL
• Scheduled to undergo or has already undergone an endovascular intervention of a de novo lesion in the SFA with an anticipated result that would satisfy hemodynamic stability OR is medically managed and does not require an intervention at this time
• Compressible arteries (if not, has toe brachial index [TBI] less than 0.7)
• Has/had an A, B, C lesion amendable to a catheter based therapy (prior bypass is acceptable)

Exclusion Criteria:

• Non-atherosclerotic disease that is responsible for claudication
• Unstable cardiac disease (e.g., unstable angina, heart attack within the 30 days before study entry, uncontrolled coronary heart failure, poorly controlled hypertension [systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg], ventricular arrhythmias)
• Pancreatitis
• Documented hypercoagulable state
• Clinically severe diabetic neuropathy
• Rest pain, gangrene, or tissue loss
• Active peptic ulcer disease or a recent gastrointestinal bleed that would prohibit the use of an anti-platelet (aspirin/Plavix)
• Untreated or unsuccessfully controlled psychiatric disease
• Chronic hepatic disease determined by aspartate transaminase (AST) and/or alanine transaminase (ALT) more than 3 times upper limit of normal (ULN) and/or total bilirubin more than 2 times ULN
• Creatine phosphokinase (CPK) more than 3 times ULN (may be repeated once before patient is excluded)
• Active gout symptoms or a uric acid level greater than 1.3 times ULN
• Untreated hypothyroidism
• Allergy to Plavix, nickel, titanium, niacin, Ezetimibe, statins, or their derivatives
• Participated in another interventional study within the 30 days before study entry
• Scheduled to undergo planned synchronous bilateral percutaneous transluminal angioplasty (PTA) procedures
• Requires an above the ankle amputation
• Scheduled to undergo elective surgery within 30 days after the PTA procedure
• Has an implanted pacemaker, defibrillator, neural stimulator, brain clip, insulin pump, cochlear implant, or any other predetermined radiographic finding that would exclude MRI testing
• Has claustrophobia that would prevent MRI testing
• Recent drug or alcohol abuse history (less than 6 months before study entry) or is currently using or abusing excessive alcohol or drugs (excessive alcohol will be defined as greater than 14 drinks per week)
• Past recipient of a cardiac, kidney, liver, lung, or other organ transplant (skin grafts are acceptable)