Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
Public ClinicalTrials.gov record NCT02063672. 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-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
Study identification
- NCT ID
- NCT02063672
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 82 participants
Conditions and interventions
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
- Feb 28, 2014
- Primary completion
- Feb 12, 2017
- Completion
- Feb 28, 2019
- Last update posted
- Apr 10, 2019
2014 – 2019
United States locations
- U.S. sites
- 20
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology Associates | Fairhope | Alabama | 36532 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | — |
| Radiology and Imaging Specialists of Lakeland, P.A. | Lakeland | Florida | 33805 | — |
| Mount Sinai Medical Center | Miami | Florida | 33140 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| William Beaumont Hospital Research Institute | Royal Oak | Michigan | 48073 | — |
| Metropolitan Hospital d/b/a Metro Health Hospital | Wyoming | Michigan | 49519 | — |
| Minneapolis Radiology and Vascular Research Foundation | Plymouth | Minnesota | 55441 | — |
| Hattiesburg Clinic, PA | Hattiesburg | Mississippi | 39401 | — |
| Jackson Heart Clinic, P.A. | Jackson | Mississippi | 39216 | — |
| Kansas City Vascular Foundation | North Kansas City | Missouri | 64116 | — |
| Hunterdon Cardiovascular Associates | Flemington | New Jersey | 08822 | — |
| Rex Hospital, Inc. | Raleigh | North Carolina | 27607 | — |
| TriHealth, Inc. | Cincinnati | Ohio | 45220 | — |
| The Miriam Hospital - A Lifespan Partner | Providence | Rhode Island | 02906 | — |
| Wellmont Cardiology Services, Inc. | Kingsport | Tennessee | 37660 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02063672, 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 Apr 10, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02063672 live on ClinicalTrials.gov.