Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery
Public ClinicalTrials.gov record NCT00933270. 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
Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, multicenter, non-randomized, single arm, pivotal trial. The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.
Study identification
- NCT ID
- NCT00933270
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 325 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 2009 (Type not available)
- Primary completion
- May 2014 (Actual)
- Completion
- Jul 2014 (Actual)
- Last update posted
- May 30, 2017
2009 – 2014
United States locations
- U.S. sites
- 49
- U.S. states
- 24
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology Associates of Mobile, Inc. | Fairhope | Alabama | 36532 | — |
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | — |
| Tucson Medical Center | Tucson | Arizona | 85712 | — |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| ACT / CVRI & Cedar Sinai Medical Center | Beverly Hills | California | 90210 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Bradenton Cardiology Center | Bradenton | Florida | 34205 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | — |
| Mount Sinai Medical Cente | Miami Beach | Florida | 33140 | — |
| Clarian North / Heart Partners | Fishers | Indiana | 46038 | — |
| Cardiovascular Research of Northwest Indiana, LLC | Munster | Indiana | 46321 | — |
| Hutchinson Hospital Corporation dba Promise Regional Medical Center | Hutchinson | Kansas | 67502 | — |
| Willis Knighton Bossier Medical Center | Bossier City | Louisiana | 71111 | — |
| Terrebonne General Hospital | Houma | Louisiana | 70360 | — |
| Cardiovascular Institute of the South | Lafayette | Louisiana | 70506 | — |
| Opelousas General Health System | Opelousas | Louisiana | 70570 | — |
| Louisiana Heart Center | Slidell | Louisiana | 70458 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Montgomery General Hospital | Olney | Maryland | 20832 | — |
| Massachussetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Caritas-St. Elizabeth Medical Center | Brighton | Massachusetts | 02135 | — |
| Metro Health Hospital | Wyoming | Michigan | 49519 | — |
| Hattiesburg Clinic, P.A. | Hattiesburg | Mississippi | 39401 | — |
| Deborah Heart | Browns Mills | New Jersey | 08015 | — |
| Hunterdon Medical Center | Flemington | New Jersey | 08822 | — |
| Robert Wood Johnson UMDNJ-RWJMS | New Brunswick | New Jersey | 08903 | — |
| SJH Cardiology Associates | Liverpool | New York | 13088 | — |
| NYU Medical Center | New York | New York | 10016 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| University Hospital | Cleveland | Ohio | 44104 | — |
| Ohio Health Research Institute / Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Heritage Valley Health System | Beaver | Pennsylvania | 15009 | — |
| Cardiology Consultants or Mainline Health System | Bryn Mawr | Pennsylvania | 19010 | — |
| Moffitt Heart & Vascular Group | Wormleysburg | Pennsylvania | 17043 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Greenville Hospital Systems | Greenville | South Carolina | 29605 | — |
| Forsyth Medical Center - Cardiovascular Research | Winston-Salem | South Carolina | 27103 | — |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37660 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | — |
| Alice Heart Center | Alice | Texas | 78332 | — |
| Austin Heart, P.A | Austin | Texas | 78756 | — |
| Cardiovascular Specialist of Texas & North Austin Medical Center | Austin | Texas | 78758 | — |
| Cardiovascular Research Institute of Dallas | Dallas | Texas | 75231 | — |
| Plaza Medical Center of Fort Worth | Fort Worth | Texas | 76104 | — |
| North Cascade Cardiology, PLLC | Bellingham | Washington | 98225 | — |
| Columbia - St. Mary's | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00933270, 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 May 30, 2017 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00933270 live on ClinicalTrials.gov.