Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Public ClinicalTrials.gov record NCT01870401. 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 Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)
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 (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
Study identification
- NCT ID
- NCT01870401
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 442 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
- Jun 3, 2013 (Actual)
- Primary completion
- May 17, 2018 (Actual)
- Completion
- Jun 22, 2021 (Actual)
- Last update posted
- Feb 9, 2022
2013 – 2021
United States locations
- U.S. sites
- 33
- U.S. states
- 23
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University-Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Cardiovascular Solutions Institute, LLC | Bradenton | Florida | 34208 | — |
| Morton Plant Mease Health Care, Inc | Clearwater | Florida | 33756 | — |
| Cardiovascular Research of North Florida, LLC | Gainesville | Florida | 32605 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Radiology and Imaging Specialists of Lakeland, P.A | Lakeland | Florida | 33805 | — |
| Mt. Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | — |
| Central Iowa Hospital Corporation | West Des Moines | Iowa | 50266 | — |
| CIS Clinical Research Corporation | Houma | Louisiana | 70360 | — |
| Steward St. Elizabeth Medical Center of Boston | Boston | Massachusetts | 02135 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Metro Health-University of Michigan Health Hospital | Wyoming | Michigan | 49519 | — |
| Jackson Heart Clinic, P.A. | Jackson | Mississippi | 39216 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Deborah Heart & Lung Ctr | Browns Mills | New Jersey | 08015 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| New Mexico Heart Institute, LLC | Albuquerque | New Mexico | 87102 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | — |
| Trihealth Heart Institute | Cincinnati | Ohio | 45220 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| OhioHealth Corporation | Columbus | Ohio | 43214-3907 | — |
| Providence Health & Service - Oregon | Portland | Oregon | 97225 | — |
| The Miriam Hospital - A Lifespan Partner | Providence | Rhode Island | 02906 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University Surgical Associates, LLC | Chattanooga | Tennessee | 37403 | — |
| Wellmont Cardiology Services, Inc. | Kingsport | Tennessee | 37660 | — |
| Austin Heart PLLC | Austin | Texas | 78756 | — |
| Sentara Medical Group | Norfolk | Virginia | 23507 | — |
| Charleston Area Medical Center Health System | Charleston | West Virginia | 25304 | — |
| Aurora St. Luke's Vascular Center | 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 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01870401, 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 Feb 9, 2022 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01870401 live on ClinicalTrials.gov.