Peripheral Artery DiseasePhase 1NCT01616290
Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
A Phase 1 study testing PRT-201 in people with Peripheral Artery Disease, run by Proteon Therapeutics at 2 sites in United States.
Trial summary
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- PRT-201
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 18 years
- Clinical diagnosis of PAD, secondary to atherosclerosis affecting a lower limb
- Rutherford classification 2-4 (moderate claudication to ischemic rest pain)
- ABI <0.90 at rest or with exercise, or a toe-brachial index <0.70, or radiographic evidence of PAD that correlates with clinical symptoms
- De novo lesion, not previously treated by angioplasty or atherectomy
- Greater than 70% stenosis of the SFA or PA, target lesion length of 10 cm or less, and at least one patent runoff vessel. Short segment occlusions (<10 cm) are acceptable
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- 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
Who cannot join
- Previous treatment with PRT-201
- 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)
- Current severe critical limb ischemia defined as ulceration or gangrene
- Planned atherectomy of the arteries of the index leg
- Prior or planned stenting of the target lesion
- Prior bypass surgery to the target SFA or PA
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- Severe concentric medial calcification of the target lesion thought to interfere with drug delivery to the adventitia that is defined subjectively by the Investigator based on fluoroscopic appearance.
- History of metastatic cancer
- Presence of aortic or peripheral artery aneurysm
- Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal
- 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
- 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 contrast media
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco VA Medical Center
San Francisco, California, 94121-9935
University of California, San Francisco Medical Center
San Francisco, California, 94143-0957
About this study
Official title: Open-Label, Dose-Escalation, Pilot Study of PRT-201 Administered Following Angioplasty in Patients With Peripheral Artery Disease in the Lower Extremity
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).
- Conditions
- Peripheral Artery Disease
- Being tested
- PRT-201
- Keywords
- peripheral artery disease, PAD, claudication, angioplasty, percutaneous transluminal angioplasty, PTA, superficial femoral artery, SFA, popliteal artery, PA, PRT-201, restenosis, vonapanitase
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT-201Drug
0.03, 1, or 3 mg single adventitial administration
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Safety
Safety evaluations will be based on adverse events, physical examinations, ultrasounds, vital signs, and clinical laboratory results. Events of interest (EOI) include: acute occlusion, vessel dissection, vessel rupture, aneurysm, pseudoaneurysm, target lesion revascularization, limb amputation, and death.
Measured: 12 months following PTA and study drug administration
Secondary outcomes (1)
Technical success of adventitial administration of PRT-201
Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery by the study drug. A standardized scale will be used to grade the pattern of distribution for each patient.
Measured: Immediately following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Christopher D Owens, M.D., M.Sc, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616290
- Sponsor's protocol ID
- PRT-201-103
- Status last verified
- Aug 2015
- First submitted
- 6 Jun 2012
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Dose-Escalation, Pilot Study of PRT-201 Administered Following Angioplasty in Patients With Peripheral Artery Disease in the Lower Extremity
- ClinicalTrials.gov ID
- NCT01616290
- Acronym / sponsor ID
- PRT-201-103
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral artery disease, PAD, claudication, angioplasty, percutaneous transluminal angioplasty, PTA, superficial femoral artery, SFA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Proteon TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of at least 18 years
- Clinical diagnosis of PAD, secondary to atherosclerosis affecting a lower limb
- Rutherford classification 2-4 (moderate claudication to ischemic rest pain)
- ABI <0.90 at rest or with exercise, or a toe-brachial index <0.70, or radiographic evidence of PAD that correlates with clinical symptoms
- De novo lesion, not previously treated by angioplasty or atherectomy
Key exclusion criteria (14 listed)
- Previous treatment with PRT-201
- 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)
- Current severe critical limb ischemia defined as ulceration or gangrene
- Planned atherectomy of the arteries of the index leg
- Prior or planned stenting of the target lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRT-2010.03, 1, or 3 mg single adventitial administration | Drug | – |
Primary outcome
Clinical Safety
Time frame: 12 months following PTA and study drug administration
Safety evaluations will be based on adverse events, physical examinations, ultrasounds, vital signs, and clinical laboratory results. Events of interest (EOI) include: acute occlusion, vessel dissection, vessel rupture, aneurysm, pseudoaneurysm, target lesion revascularization, limb amputation, and death.
1 secondary outcome
Technical success of adventitial administration of PRT-201
Time frame: Immediately following study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Owens, M.D., M.Sc principal investigator
San Francisco VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRT-201 in people with Peripheral Artery Disease, run by Proteon Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Safety (time frame: 12 months following PTA and study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.