Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
This study is currently recruiting participants.
Verified October 2012 by Proteon Therapeutics
Sponsor:
Proteon Therapeutics
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Proteon Therapeutics
ClinicalTrials.gov Identifier:
NCT01616290
First received: June 6, 2012
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following angioplasty (PTA).
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Artery Disease |
Drug: PRT-201 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label, Dose-Escalation, Pilot Study of PRT-201 Administered Following Angioplasty in Patients With Peripheral Artery Disease in the Lower Extremity |
Resource links provided by NLM:
Further study details as provided by Proteon Therapeutics:
Primary Outcome Measures:
- Clinical Safety [ Time Frame: 12 months following PTA and study drug administration ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Technical success of adventitial administration of PRT-201 [ Time Frame: Immediately following study drug administration ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 16 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: PRT-201
1, 3, 10 or 30 mg single adventitial administration
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
- Resting ankle-brachial index (ABI) <0.90
- De novo lesion, not previously treated by angioplasty or atherectomy
- Greater than 70% stenosis of the SFA or PA and target lesion length of 10 cm or less
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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616290
Contacts
| Contact: Hugh F Alley | 415-221-4810 ext 4708 | Hugh.Alley@ucsfmedctr.org |
Locations
| United States, California | |
| San Francisco VA Medical Center | Recruiting |
| San Francisco, California, United States, 94121-9935 | |
| Contact: Hugh F Alley 415-221-4810 ext 4708 Hugh.Alley@ucsfmedctr.org | |
| Contact: Christine Hall 415-221-4810 ext 2115 Christine.Hall@ucsfmedctr.org | |
| Principal Investigator: Christopher D Owens, M.D., M.Sc | |
| University of California, San Francisco Medical Center | Not yet recruiting |
| San Francisco, California, United States, 94143-0957 | |
| Contact: Joy Walker, M.D. 415-353-4366 Joy.PeacockWalker@ucsfmedctr.org | |
| Contact: Julia Sobel 415-353-4379 Julia.Sobel@ucsfmedctr.org | |
| Sub-Investigator: Charles M Eichler, M.D. | |
Sponsors and Collaborators
Proteon Therapeutics
University of California, San Francisco
Investigators
| Principal Investigator: | Christopher D Owens, M.D., M.Sc | San Francisco VA Medical Center |
More Information
No publications provided
| Responsible Party: | Proteon Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01616290 History of Changes |
| Other Study ID Numbers: | PRT-201-103 |
| Study First Received: | June 6, 2012 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Proteon Therapeutics:
|
peripheral artery disease PAD claudication angioplasty percutaneous transluminal angioplasty PTA |
superficial femoral artery SFA popliteal artery PA PRT-201 restenosis |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013