ClinicalTrials.gov record
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
ClinicalTrials.gov ID: NCT02424383
Public ClinicalTrials.gov record NCT02424383. 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, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)
Study identification
- NCT ID
- NCT02424383
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- C. R. Bard
- Industry
- Enrollment
- 1,005 participants
Conditions and interventions
Interventions
- PTA (Lutonix® 035 DCB Catheter) Device
Device
Eligibility (public fields only)
- Age range
- 21 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
- Apr 22, 2015
- Primary completion
- Oct 26, 2017
- Completion
- Oct 20, 2019
- Last update posted
- May 21, 2020
2015 – 2019
United States locations
- U.S. sites
- 73
- U.S. states
- 34
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lake Martin Laser and Vein Institute | Alexander City | Alabama | 35010 | — |
| Chandler Regional Medical Center | Chandler | Arizona | 85224 | — |
| St. Luke's Hospital- Phoenix | Phoenix | Arizona | 85006 | — |
| UCSD Health System | San Diego | California | 92093 | — |
| Colorado Heart and Vascular | Lakewood | Colorado | 80228 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | — |
| Research Physicians Network Alliance | Boynton Beach | Florida | 33435 | — |
| Bradenton Cardiology Center | Bradenton | Florida | 34205 | — |
| Clearwater Cardiovascular & Interventional Consultants | Clearwater | Florida | 33756 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32207 | — |
| Sarah Cannon Research Institute, LLC | Jacksonville | Florida | 32216 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northside Hospital, Inc | Atlanta | Georgia | 30342 | — |
| Vascular Interventional of Thomasville, Associates | Thomasville | Georgia | 31792 | — |
| Kaiser Foundation Hospitals | Honolulu | Hawaii | 96819 | — |
| Peoria Radiology & Research Foundation | Peoria | Illinois | 61637 | — |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | — |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | — |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Hutchinson Regional Medical Center - Hutchinson, Inc | Hutchinson | Kansas | 67502 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| MedStar Health Research Institute | Annapolis | Maryland | 21401 | — |
| Cape Cod Research Institute | Hyannis | Massachusetts | 02601 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | — |
| DLP Marquette General Hospital | Marquette | Michigan | 49855 | — |
| Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital | Petoskey | Michigan | 49770 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| Merit Health Wesley | Hattiesburg | Mississippi | 39402 | — |
| Freeman Health System | Joplin | Missouri | 64804 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Cardiovascular Associates of Delaware Valley | Haddon Heights | New Jersey | 08035 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07754 | — |
| New York Hospital-Queens | Flushing | New York | 11355 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| The Feinstein Institute for Medical Research | New York | New York | 10075 | — |
| The Research Foundation for Suny | Syracuse | New York | 13210 | — |
| CaroMont Heart Clinical Research | Gastonia | North Carolina | 28054 | — |
| LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | — |
| Carolina East Health System | New Bern | North Carolina | 28562 | — |
| Rex Hospital, Inc | Raleigh | North Carolina | 27607 | — |
| Mercy West Hospital | Cincinnati | Ohio | 45211 | — |
| Jobst Vascular Institute | Toledo | Ohio | 43603 | — |
| Jane Phillips Memorial Medical Center | Bartlesville | Oklahoma | 74006 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| Integris Baptist Medical Center, Inc | Oklahoma City | Oklahoma | 73112 | — |
| Providence Health & Service | Portland | Oregon | 97225 | — |
| Lankenau Institute for Medical Research | Bryn Mawr | Pennsylvania | 19010 | — |
| Saint Vincent Consultants in Cardiovascular Diseases | Erie | Pennsylvania | 16502 | — |
| Heart Institute at Largo | Harrisburg | Pennsylvania | 17110 | — |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | — |
| Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania | 17043 | — |
| The Miriam Hospital - A Lifespan Partner | Providence | Rhode Island | 02906 | — |
| Vascular Access Solutions | Orangeburg | South Carolina | 29118 | — |
| Stern Cardiovascular Foundation, Inc | Germantown | Tennessee | 38138 | — |
| Stern Cardiovascular Foundation Inc. | Memphis | Tennessee | 38120 | — |
| Seton Heart Institute | Austin | Texas | 78705 | — |
| Cardiovascular Specialists of Texas | Austin | Texas | 78758 | — |
| Methodist Health System Clinical Research Institute | Dallas | Texas | 75203 | — |
| El Paso Cardiology Associates, P.A. | El Paso | Texas | 79902 | — |
| Houston Methodist Research Institute | Houston | Texas | 77030 | — |
| Virginia Cardiovascular Specialists | Richmond | Virginia | 23225 | — |
| Sentara Medical Group | Virginia Beach | Virginia | 23542 | — |
| Lake Washington Vascular, PLLC | Bellevue | Washington | 98004 | — |
| CAMC Health Education and Research Institute | Charleston | West Virginia | 25304 | — |
| Bellin Memorial Hospital, Inc | Green Bay | Wisconsin | 54301 | — |
| Wisconsin Heart-Meriter | Madison | Wisconsin | 53713 | — |
| Columbia St. Mary's, Inc. | 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 NCT02424383, 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 21, 2020 · Synced May 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02424383 live on ClinicalTrials.gov.