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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Proteon Therapeutics
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Proteon Therapeutics
ClinicalTrials.gov Identifier:
NCT01616290
First received: June 6, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Peripheral Artery Disease
Drug: PRT-201
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Proteon Therapeutics:

Primary Outcome Measures:
  • Clinical Safety [ Time Frame: 12 months following PTA and study drug administration ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 16
Study Start Date: October 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PRT-201
    0.03, 1, or 3 mg single adventitial administration
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616290

Contacts
Contact: Hugh F Alley 415-221-4810 ext 4708 Hugh.Alley@ucsfmedctr.org

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121-9935
Contact: Hugh F Alley    415-221-4810 ext 4708    Hugh.Alley@ucsfmedctr.org   
Contact: Christine Hall    415-221-4810 ext 2115    Christine.Hall@ucsfmedctr.org   
Principal Investigator: Christopher D Owens, M.D., M.Sc         
University of California, San Francisco Medical Center Not yet recruiting
San Francisco, California, United States, 94143-0957
Contact: Joy Walker, M.D.    415-353-4366    Joy.PeacockWalker@ucsfmedctr.org   
Contact: Julia Sobel    415-353-4379    Julia.Sobel@ucsfmedctr.org   
Sub-Investigator: Charles M Eichler, M.D.         
Sponsors and Collaborators
Proteon Therapeutics
University of California, San Francisco
Investigators
Principal Investigator: Christopher D Owens, M.D., M.Sc San Francisco VA Medical Center
  More Information

No publications provided

Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT01616290     History of Changes
Other Study ID Numbers: PRT-201-103
Study First Received: June 6, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Proteon Therapeutics:
peripheral artery disease
PAD
claudication
angioplasty
percutaneous transluminal angioplasty
PTA
superficial femoral artery
SFA
popliteal artery
PA
PRT-201
restenosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014