Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
To assess the safety and effectiveness of adventitial deposition of the Study Drug in
reducing inflammation and restenosis in patients with clinical evidence of claudication or
critical limb ischemia and an angiographically significant lesion in the superficial femoral
and/or popliteal arteries.
Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute
contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel
treatment length.