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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention

NCT04848220

Microvascular Obstruction

TERMINATED PHASE2

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

NCT07223593

Peripheral Arterial Disease

RECRUITING PHASE3

Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial

NCT03358355

Peripheral Artery Disease PAD Peripheral Arterial Disease

COMPLETED PHASE1/PHASE2

A Trial of Low-dose Adjunctive alTeplase During prIMary PCI

NCT02257294

Myocardial Infarction

COMPLETED PHASE2

Trial of VLTS-589 in Subjects With Intermittent Claudication

NCT00068133

Intermittent Claudication Peripheral Vascular Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vonapanitase

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

Group Type ACTIVE_COMPARATOR

vonapanitase

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vonapanitase

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PRT-201

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

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:

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No