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NCT01616290 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
A Phase 1 study of Peripheral Artery Disease, sponsored by Proteon Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT01616290: Completed Phase 1 study of Peripheral Artery Disease, sponsored by Proteon Therapeutics.
NCT01616290 is a Phase 1 study of Peripheral Artery Disease that has completed, run by Proteon Therapeutics. The registered enrollment target is 14 participants, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01616290, a Phase 1 study of Peripheral Artery Disease, has completed, sponsored by Proteon Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG PRT-201
Study Locations (2)
California
- San Francisco VA Medical Center - San Francisco
- University of California, San Francisco Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01616290 record still lists
NCT01616290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which PRT-201 is the first listed.
NCT01616290 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01616290 about?
NCT01616290 is a clinical study titled "Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)". 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).
What is the current status of trial NCT01616290?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-10. Estimated completion is 2015-07.
What conditions does trial NCT01616290 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT01616290?
The interventions under investigation include: PRT-201 (DRUG).
Who is sponsoring clinical trial NCT01616290?
This trial is sponsored by Proteon Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01616290 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Peripheral Artery Disease
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Where NCT01616290's enrollment target sits among peer trials
14 45th of 50 higher than 6 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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