Peripheral Artery Disease
Conditions
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
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.
Interventions
DRUGvonapanitase
DRUGPlacebo
Sponsors
Proteon Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Up to 6 months following study drug administration | Safety assessments include physical exams and routine serum chemistry and hematology tests |
| Technical success of perivascular injection | 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
| Measure | Time frame |
|---|---|
| Incidence of arterial occlusion | 14 days and 6 months following study drug administration |
| Rutherford category | 14 and 28 days, and 6 months following study drug administration |
| Minimum lumen diameter [MLD] | Intraprocedural and 6 months following study drug administration |
| Vascular Quality of Life Questionnaire-6 [VascuQol-6 | 14 days and 6 months following study drug administration |
| Ankle-brachial index [ABI] | 14 days and 6 months following study drug administration |
| Minimum lumen area [MLA] | Intraprocedural and 6 months following study drug administration |
Countries
United States
Outcome results
None listed