Endovascular Atherectomy Safety and Effectiveness Study
Public ClinicalTrials.gov record NCT01541774. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multicenter Clinical Evaluation of the Safety and Effectiveness of the Phoenix Atherectomy™ System in Atherectomy of the Peripheral Vasculature
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is intended for use in atherectomy of the peripheral vasculature. The intended peripheral vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of this study will be used to support a 510(k) submission to the Food and Drug Administration.
Study identification
- NCT ID
- NCT01541774
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2010
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
- Last update posted
- Jan 30, 2014
2010 – 2013
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spring Hill Medical Center | Mobile | Alabama | 36608 | — |
| Arizona Heart Institute | Phoenix | Arizona | 85016 | — |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| Vascular Interventional Center | Pensacola | Florida | 32504 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| WellStar Health System | Austell | Georgia | 30106 | — |
| Methodist Research Imstitute /Cobb Hospital | Indianapolis | Indiana | 46202 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| Cardiovascular Inst The Regional Med Center/Center of Acadia Institute of the South | Lafayette | Louisiana | 70506 | — |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Hunterdon Cardiovascular Associated | Flemington | New Jersey | 08822 | — |
| Columbia University Medical Center/New York Presbyterian | New York | New York | 10032 | — |
| The Carl & Eduth Lindner Center for Research & Education at the Christ Hospital | Kingsport | Tennessee | 37660 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01541774, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2014 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01541774 live on ClinicalTrials.gov.