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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01616290
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : August 11, 2015
University of California, San Francisco
Information provided by (Responsible Party):
Proteon Therapeutics

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: PRT-201 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Dose-Escalation, Pilot Study of PRT-201 Administered Following Angioplasty in Patients With Peripheral Artery Disease in the Lower Extremity
Study Start Date : October 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: PRT-201
    0.03, 1, or 3 mg single adventitial administration

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age of at least 18 years
  2. Clinical diagnosis of PAD, secondary to atherosclerosis affecting a lower limb
  3. Rutherford classification 2-4 (moderate claudication to ischemic rest pain)
  4. 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
  5. De novo lesion, not previously treated by angioplasty or atherectomy
  6. 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
  7. 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
  8. Ability to understand and comply with the requirements of the entire study and communicate with the study team
  9. Ability to provide written informed consent using a document that has been approved by the required institutional review board

Exclusion Criteria:

  1. Previous treatment with PRT-201
  2. 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)
  3. Current severe critical limb ischemia defined as ulceration or gangrene
  4. Planned atherectomy of the arteries of the index leg
  5. Prior or planned stenting of the target lesion
  6. Prior bypass surgery to the target SFA or PA
  7. 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.
  8. History of metastatic cancer
  9. Presence of aortic or peripheral artery aneurysm
  10. Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal
  11. Pregnancy, lactation or plans to become pregnant during the course of the study
  12. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study
  13. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent
  14. Known allergy to contrast media

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01616290

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United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121-9935
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143-0957
Sponsors and Collaborators
Proteon Therapeutics
University of California, San Francisco
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Principal Investigator: Christopher D Owens, M.D., M.Sc San Francisco VA Medical Center

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Responsible Party: Proteon Therapeutics Identifier: NCT01616290    
Other Study ID Numbers: PRT-201-103
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by Proteon Therapeutics:
peripheral artery disease
percutaneous transluminal angioplasty
superficial femoral artery
popliteal artery
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases