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Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)

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ClinicalTrials.gov Identifier: NCT02956993
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics

Brief Summary:
The research study is designed to assess the technical feasibility and safety of a perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal popliteal, tibial or peroneal arteries immediately following successful angioplasty.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: vonapanitase Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Vonapanitase Administered Following Angioplasty of a Distal Popliteal, Tibial or Peroneal Artery in Patients With Peripheral Artery Disease
Study Start Date : November 2016
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

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Arm Intervention/treatment
Active Comparator: Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
Drug: vonapanitase
Other Name: PRT-201

Placebo Comparator: Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
Drug: Placebo



Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 6 months following study drug administration ]
    Safety assessments include physical exams and routine serum chemistry and hematology tests

  2. Technical success of perivascular injection [ Time Frame: Intraprocedural ]
    Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery using a protocol-defined assessment scale


Other Outcome Measures:
  1. Minimum lumen diameter [MLD] [ Time Frame: Intraprocedural and 6 months following study drug administration ]
  2. Minimum lumen area [MLA] [ Time Frame: Intraprocedural and 6 months following study drug administration ]
  3. Incidence of arterial occlusion [ Time Frame: 14 days and 6 months following study drug administration ]
  4. Rutherford category [ Time Frame: 14 and 28 days, and 6 months following study drug administration ]
  5. Ankle-brachial index [ABI] [ Time Frame: 14 days and 6 months following study drug administration ]
  6. Vascular Quality of Life Questionnaire-6 [VascuQol-6 [ Time Frame: 14 days and 6 months following study drug administration ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Screening: Initial study inclusion criteria

  1. Age of at least 18 years.
  2. Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
  3. Rutherford category 3-5.
  4. De novo lesion, not previously treated by angioplasty, atherectomy or stenting.
  5. Scheduled to undergo angioplasty of the distal popliteal, tibial or peroneal arteries.
  6. 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.
  7. Ability to understand and comply with the requirements of the entire study and communicate with the study team.
  8. Ability to provide written informed consent using a document that has been approved by the required institutional review board.

    Procedure: Study inclusion criteria to be determined at the time of the angioplasty procedure

  9. Atherosclerotic lesion with >50% stenosis in the popliteal (distal to the center of the knee joint space, the P3 segment), tibial or peroneal artery prior to angioplasty.
  10. Successful revascularization without the use of stenting of the target lesion; no flow limiting dissection and <30% residual lumen stenosis as compared with an adjacent non-diseased lumen diameter.

Exclusion Criteria Screening: Initial study exclusion criteria

  1. 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).
  2. Planned above ankle amputation on ipsilateral limb within 4 weeks of study drug administration.
  3. Prior or planned stenting of the target lesion.
  4. Deep vein thrombosis within the past 3 months.
  5. Known bleeding disorder.
  6. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden, prothrombin G20210A mutation).
  7. Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal.
  8. Renal failure with existing dependence on dialysis or an eGFR by MDRD calculation of < 20 mL/min/1.73 m2.
  9. Pregnancy, lactation or plans to become pregnant during the course of the study.
  10. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
  11. Malignancy or treatment for malignancy within the previous 12 months with the exception of localized basal cell or squamous cell skin cancer, or any cancer in situ.
  12. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
  13. Known allergy to radiocontrast agents.

    Procedure:

    Exclusion criteria to be determined at the time of the angioplasty procedure

  14. Reference vessel diameter < 2 mm and > 8 mm.
  15. Severe concentric medial calcification of the target lesion thought to interfere with study drug delivery to the adventitia based on fluoroscopic appearance.
  16. Aneurysm in the target vessel.
  17. Failure to cross the target lesion with a guide wire; however subintimal wire crossing is allowed.
  18. Stenting of the target lesion.

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 ClinicalTrials.gov identifier (NCT number): NCT02956993


Locations
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United States, California
VA Medical Center Long Beach
Long Beach, California, United States, 90822
United States, Colorado
VA Eastern Colorado Healthcare System
Denver, Colorado, United States, 80220
United States, Florida
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Steward St. Elizabeth's Medical
Boston, Massachusetts, United States, 02135
United States, Michigan
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Texas
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States, 78756
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Proteon Therapeutics

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Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT02956993     History of Changes
Other Study ID Numbers: PRT-201-115
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Keywords provided by Proteon Therapeutics:
peripheral artery disease
PAD
vonapanitase
critical limb ischemia
CLI
tibial artery
stenosis
distal popliteal artery
peroneal artery
below the knee
BTK
elastase
chymotrypsin-like elastase 1
CELA1
PRT-201
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases