Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)

Inclusion criteria

• Age of at least 18 years
• Clinical diagnosis of PAD, secondary to atherosclerosis affecting a lower limb
• Rutherford classification 2-4 (moderate claudication to ischemic rest pain)
• ABI <0.90 at rest or with exercise, or a toe-brachial index <0.70, or radiographic evidence of PAD that correlates with clinical symptoms
• De novo lesion, not previously treated by angioplasty or atherectomy
• Greater than 70% stenosis of the SFA or PA, target lesion length of 10 cm or less, and at least one patent runoff vessel. Short segment occlusions (<10 cm) are acceptable
• If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 1 week following study drug administration. Acceptable methods of birth control include abstinence, barrier methods with spermicide, implants, injectables, oral contraceptives, intra-uterine device, or a vasectomized partner
• Ability to understand and comply with the requirements of the entire study and communicate with the study team
• Ability to provide written informed consent using a document that has been approved by the required institutional review board

Exclusion criteria

• Previous treatment with PRT-201
• Patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g. Buerger's disease, vasculitis)
• Current severe critical limb ischemia defined as ulceration or gangrene
• Planned atherectomy of the arteries of the index leg
• Prior or planned stenting of the target lesion
• Prior bypass surgery to the target SFA or PA
• Severe concentric medial calcification of the target lesion thought to interfere with drug delivery to the adventitia that is defined subjectively by the Investigator based on fluoroscopic appearance.
• History of metastatic cancer
• Presence of aortic or peripheral artery aneurysm
• Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal
• Pregnancy, lactation or plans to become pregnant during the course of the study
• Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study
• Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent
• Known allergy to contrast media