- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616290
Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
August 7, 2015 updated by: Proteon Therapeutics
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94121-9935
- San Francisco VA Medical Center
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San Francisco, California, United States, 94143-0957
- University of California, San Francisco Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Safety
Time Frame: 12 months following PTA and study drug administration
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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.
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12 months following PTA and study drug administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical success of adventitial administration of PRT-201
Time Frame: Immediately following study drug administration
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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.
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Immediately following study drug administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher D Owens, M.D., M.Sc, San Francisco VA Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
June 6, 2012
First Submitted That Met QC Criteria
June 7, 2012
First Posted (Estimate)
June 11, 2012
Study Record Updates
Last Update Posted (Estimate)
August 11, 2015
Last Update Submitted That Met QC Criteria
August 7, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRT-201-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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