Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
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Clinical Safety [ Time Frame: 12 months following PTA and study drug administration ]
Safety evaluations will be based on adverse events, physical examinations, ultrasounds, vital signs, and clinical laboratory results. Events of interest (EOI) include: acute occlusion, vessel dissection, vessel rupture, aneurysm, pseudoaneurysm, target lesion revascularization, limb amputation, and death.
Secondary Outcome Measures :
Technical success of adventitial administration of PRT-201 [ Time Frame: Immediately following study drug administration ]
Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery by the study drug. A standardized scale will be used to grade the pattern of distribution for each patient.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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