The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

Exclusion Criteria

• •Hypotension defined as a systolic blood pressure less than 100mmhg systolic at screening or baseline visit
• •Critical Leg Ischemia (Rutherford Classification IV, V, VI)
• •Surgical intervention to alleviate symptoms of claudication in the study leg within the past 6 months or any endovascular interventions within 3 months or who is scheduled to undergo surgical revascularization in the next 6 month
• •Walking limited by reasons other than claudication (e.g. arthritis, lung disease, severe neuropathy, lower extremity amputation except single digits)
• •Serum creatinine \>1.5mg/dl or Hepatic enzymes \>2X the upper limit of normal
• •Serum potassium greater than 5.0 or use of a potassium sparing diuretic at screening
• •Pregnant, breast feeding or planning to become pregnant (subject or partner) at any time during the study.
• •Myocardial Infarction, Cerebrovascular Accident or deep vein thrombosis within 12 months of screening
• •Known history of nephrolithiasis
• •History of ever having a seizure
• •Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, organ transplant, long term immunosuppression (excluding inhaled steroids), current neoplasm or severe gastroesophageal reflux
• •History of vertigo or syncope within the past 10 years
• •Enrollment in another drug or device study within 30 days of screening
• •Required treatment with a drug known to inhibit folate metabolism (e.g. Methotrexate)
• •Taking any of the following medications; PDE3 Inhibitors, PDE5 inhibitors, trental, nitrates, ginkgo biloba, levodopa, warfarin,
• •Axillary lymph node dissection
• •Presence of an amputation except single digits in either leg
• •Preexisting illness that limits ambulation such as severe COPD, class III-IV heart failure, severe arthritis or back pain
• •Glucose-6-dehydrogenase deficiency