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

NCT02956993 | Completed Phase 1 DMC

• 1 other identifier: PRT-201-115
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 9

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.

Conditions

Peripheral Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Safety assessments include physical exams and routine serum chemistry and hematology tests

  Up to 6 months following study drug administration

• Technical success of perivascular injection

  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

  Intraprocedural

Other Outcomes (6)

• Minimum lumen diameter [MLD]

  Intraprocedural and 6 months following study drug administration

• Minimum lumen area [MLA]

  Intraprocedural and 6 months following study drug administration

• Incidence of arterial occlusion

  14 days and 6 months following study drug administration

Study Arms (2)

Vonapanitase

ACTIVE COMPARATOR

Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.

Drug: vonapanitase

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

vonapanitase DRUG

Also known as: PRT-201

Vonapanitase

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 years.
• Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
• Rutherford category 3-5.
• De novo lesion, not previously treated by angioplasty, atherectomy or stenting.
• Scheduled to undergo angioplasty of the distal popliteal, tibial or peroneal arteries.
• 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.
• 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.
• 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.

You may not qualify if:

• 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).
• Planned above ankle amputation on ipsilateral limb within 4 weeks of study drug administration.
• Prior or planned stenting of the target lesion.
• Deep vein thrombosis within the past 3 months.
• Known bleeding disorder.
• Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden, prothrombin G20210A mutation).
• Platelet count \<130K, hematocrit \<30%, bilirubin or ALT \>3.0 times the upper limit of normal.
• Renal failure with existing dependence on dialysis or an eGFR by MDRD calculation of \< 20 mL/min/1.73 m2.
• 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.
• 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.
• 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 radiocontrast agents.
• Procedure:
• Reference vessel diameter \< 2 mm and \> 8 mm.

Sponsors & Collaborators

• Proteon Therapeutics: lead

Study Sites (9)

VA Medical Center Long Beach

Long Beach, California, 90822, United States

Location

VA Eastern Colorado Healthcare System

Denver, Colorado, 80220, United States

Location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Steward St. Elizabeth's Medical

Boston, Massachusetts, 02135, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Constriction, Pathologic

Interventions

cholesterol-binding protein

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: November 1, 2016
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

US (9)