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

Peripheral Artery Disease Clinical Trial

Official title:

Open-Label, Dose-Escalation, Pilot Study of PRT-201 Administered Following Angioplasty in Patients With Peripheral Artery Disease in the Lower Extremity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616290
• Other study ID #: PRT-201-103
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2012
• Last updated: August 7, 2015
• Start date: October 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Proteon Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age of at least 18 years

2. Clinical diagnosis of PAD, secondary to atherosclerosis affecting a lower limb

3. Rutherford classification 2-4 (moderate claudication to ischemic rest pain)

4. 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

5. De novo lesion, not previously treated by angioplasty or atherectomy

6. 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

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:

1. Previous treatment with PRT-201

2. 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)

3. Current severe critical limb ischemia defined as ulceration or gangrene

4. Planned atherectomy of the arteries of the index leg

5. Prior or planned stenting of the target lesion

6. Prior bypass surgery to the target SFA or PA

7. 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.

8. History of metastatic cancer

9. Presence of aortic or peripheral artery aneurysm

10. Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal

11. Pregnancy, lactation or plans to become pregnant during the course of the study

12. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• PRT-201
0.03, 1, or 3 mg single adventitial administration

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Proteon Therapeutics	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Immediately following study drug administration	Yes