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

Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - 100
Start Date:November 2016
End Date:January 2020
Contact:Deborah Quigley

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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

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.

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

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,

2. Planned above ankle amputation on ipsilateral limb within 4 weeks of study drug

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

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.


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.
We found this trial at
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
Charlottesville, VA
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Austin, TX
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736 Cambridge Street
Boston, Massachusetts 02135
Boston, MA
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Boston, Massachusetts 02118
Boston, MA
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Denver, Colorado 80220
Denver, CO
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2033 Mowry Road
Gainesville, Florida 32610
Gainesville, FL
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Long Beach, California 90822
Long Beach, CA
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Milwaukee, WI
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
Wyoming, MI
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