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

Study Overview
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Brief Summary
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The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).

Official Title
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Open-Label, Dose-Escalation, Pilot Study of PRT-201 Administered Following Angioplasty in Patients With Peripheral Artery Disease in the Lower Extremity

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Drug: PRT-201


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PRT-201|0.03, 1, or 3 mg single adventitial administration|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Safety | 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. | 12 months following PTA and study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of adventitial administration of PRT-201 | 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. | Immediately following study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral artery disease, PAD, claudication, angioplasty, percutaneous transluminal angioplasty, PTA, superficial femoral artery, SFA, popliteal artery, PA, PRT-201, restenosis, vonapanitase