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

Launched by LOUIS MESSINA · Mar 11, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ATLAS Therapy to see if it can help increase the levels of a substance called Nitric Oxide in the blood for people with intermittent claudication. Intermittent claudication is a condition often caused by peripheral artery disease, where patients experience pain in their legs when walking due to reduced blood flow. The researchers want to find out if boosting Nitric Oxide can help patients walk longer distances without pain and improve their overall physical activity.

To participate in this study, you need to be at least 18 years old and have been diagnosed with peripheral artery disease. Participants should also be willing to stop taking certain medications that might interfere with the study. If you join the trial, you can expect to follow specific procedures and provide consent to participate. It's important to note that certain health conditions or medications may disqualify you from participating, so a thorough screening will be done to ensure safety. Overall, this trial aims to explore a potentially helpful treatment option for those struggling with leg pain during walking.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • PAD as demonstrated by an ABI \<0 .9 in one leg or TBI less than \<0.7 in patients with an ABI \>1.3 (non compressible vessels)
• • Rutherford Classification II, III
• • Age \>18 years old
• • Willingness to discontinue phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Levitra, Revatio
• • Willingness to discontinue phosphodiesterase (PDE) 3inhibitors cilostazol, milrinone or Vesnarinone
• • Willing and able to comply with all study procedures
• • Willing and able to provide informed consent
• • Sexually active subjects willing to use an acceptable method of contraception while participating in the study
• 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