Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)

NCT01616290 | Completed Phase 1 DMC

• 1 other identifier: PRT-201-103
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Peripheral Artery Disease

Keywords

peripheral artery disease; PAD; claudication; angioplasty; percutaneous transluminal angioplasty; PTA; superficial femoral artery; SFA; popliteal artery; PA; PRT-201; restenosis; vonapanitase

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months following PTA and study drug administration

Secondary Outcomes (1)

• Technical success of adventitial administration of PRT-201

  Immediately following study drug administration

Interventions

PRT-201 DRUG

0.03, 1, or 3 mg single adventitial administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Proteon Therapeutics: lead
• University of California, San Francisco: collaborator

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94121-9935, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94143-0957, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

cholesterol-binding protein

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher D Owens, M.D., M.Sc

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 11, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

US (2)