Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
Public ClinicalTrials.gov record NCT01355406. 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
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal. The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.
Study identification
- NCT ID
- NCT01355406
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 257 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 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
- Sep 16, 2011 (Actual)
- Primary completion
- Jan 15, 2016 (Actual)
- Completion
- Apr 10, 2018 (Actual)
- Last update posted
- Jun 29, 2018
2011 – 2018
United States locations
- U.S. sites
- 36
- U.S. states
- 21
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Abrazo Health Care Clinical & Trans. Research | Phoenix | Arizona | 85006 | — |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | — |
| El Camino Hospital | Mountain View | California | 94040 | — |
| Yale University/New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Manatee Memorial Hospital | Bradenton | Florida | 34205 | — |
| Florida Research Network | Gainesville | Florida | 32605 | — |
| Memorial Hospital | Jacksonville | Florida | 32256 | — |
| Baptist Cardiac & Vascular Institute | Miami | Florida | 33176 | — |
| Mount Sinai Miami Medical Center | Miami Beach | Florida | 33140 | — |
| Florida Hospital Pepin Heart Institute | Tampa | Florida | 33613 | — |
| University Hospital | Augusta | Georgia | 30901 | — |
| St. John's Hospital | Springfield | Illinois | 62769 | — |
| Midwest Cardiovascular Research Foundation / Trinity Medical Center | Davenport | Iowa | 52803 | — |
| Healient Physician Group | Overland Park | Kansas | 66211 | — |
| Lafayette General Medical Center | Lafayette | Louisiana | 70506 | — |
| Christus St. Patrick Hospital | Lake Charles | Louisiana | 70601 | — |
| Glenwood Regional Medical Center | West Monroe | Louisiana | 71291 | — |
| Washington Adventist Hospital / Center for Cardiac & Vascular Research | Takoma Park | Maryland | 20912 | — |
| Deborah Heart | Browns Mills | New Jersey | 08015 | — |
| Cardiovascular Associates of the Delaware Valley | Haddon Heights | New Jersey | 08103 | — |
| Our Lady of Lourdes Medical Center | Haddon Heights | New Jersey | 08103 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| Gotham Cardiovascular Research, PC | New York | New York | 10001 | — |
| Columbia University Medical Center, Center for Interventional Vascular Therapy | New York | New York | 10032 | — |
| CarolinaEast Health Center | New Bern | North Carolina | 28560 | — |
| Rex Healthcare | Raleigh | North Carolina | 27607 | — |
| Sanford Research/USD/Sanford Clinic | Fargo | North Dakota | 58122 | — |
| Riverside Methodist Hospital / MidWest Cardiology Research Foundation | Columbus | Ohio | 43214 | — |
| Holy Spirit Hospital | Camp Hill | Pennsylvania | 17011 | — |
| Allegheny General Hospital/Forbes Hospital | Pittsburgh | Pennsylvania | 15146 | — |
| Miriam Hospital | Providence | Rhode Island | 02904 | — |
| Cardiovascular Research Institute of Dallas | Dallas | Texas | 75231 | — |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | — |
| Providence Sacred Heart Medical Center / Providence Spokane Cardiology | Spokane | Washington | 99204 | — |
| Wisconsin Heart Hospital | Milwaukee | Wisconsin | 53212 | — |
| Aurora St. Luke's Medical Center / Aurora Medical Group | Milwaukee | Wisconsin | 53215 | — |
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 NCT01355406, 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 Jun 29, 2018 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01355406 live on ClinicalTrials.gov.