Safety/ Feasibility of Percutaneous Administration of Vonapanitase as Monotherapy for Peripheral Artery Disease (PAD) of the SFA and Popliteal Arteries
NCT ID: NCT02953496
Last Updated: 2019-05-02
Study Results
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.
WITHDRAWN
PHASE1
INTERVENTIONAL
2019-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.
NCT02939924
Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System
NCT00542646
3 Month PHI PAD PoM Study
NCT02135848
Endovascular Treatment of Peripheral Artery Disease (PAD)
NCT03414515
To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
NCT05662618
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
vonapanitase
vonapanitase
Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
vonapanitase
Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
3. ABI \<0.90 at rest or with exercise, or a toe-brachial index (TBI) \<0.70 if ABI value is \>1.30 (non-compressible), or radiographic evidence of PAD that correlates with clinical symptoms.
4. Rutherford category 2-4.
5. Screening duplex Doppler ultrasound with a SFA or PA lesion with a PSVR \>2.4.
6. De novo lesion, not previously treated by angioplasty, atherectomy, or stent.
7. 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.
8. Ability to understand and comply with the requirements of the entire study and communicate with the study team.
9. Ability to provide written informed consent using a document that has been approved by the required institutional review board.
Exclusion Criteria
2. Total occlusion of the SFA or PA in the index leg.
3. Planned surgical or endovascular procedures to the affected leg on the day of or within 28 days of study drug administration.
4. Deep vein thrombosis within the past 3 months.
5. Known bleeding disorder.
6. Presence of any arterial aneurysm in the index leg.
7. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden mutation, prothrombin G20210A mutation).
8. Platelet count \<130K, hematocrit \<30%, bilirubin or ALT \>3.0 times the upper limit of normal.
9. Arterial systolic BP \>200 mmHg or diastolic BP \>100 mmHg at screening or day of procedure.
10. Pregnancy, lactation or plans to become pregnant during the course of the study.
11. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
12. Malignancy or treatment for malignancy within the previous 12 months with the exception localized basal cell or squamous cell skin cancer, or any cancer in situ.
13. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
14. Known allergy to contrast media, iodine, lidocaine, prilocaine, or EMLA Cream (lidocaine 2.5% and prilocaine 2.5%).
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Proteon Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRT-201-110
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.