LIFE-BTK Randomized Controlled Trial
Public ClinicalTrials.gov record NCT04227899. 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
LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed infrapopliteal lesions. Approximately 225 subjects will be randomized in a 2:1 ratio. The clinical investigation will be conducted at approximately 65 clinical sites in the US, Asia, Australia, and New Zealand.
Study identification
- NCT ID
- NCT04227899
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 261 participants
Conditions and interventions
Conditions
Interventions
Device
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
- Aug 18, 2020 (Actual)
- Primary completion
- Aug 17, 2023 (Actual)
- Completion
- Jul 2027 (Estimated)
- Last update posted
- Dec 30, 2025
2020 – 2027
United States locations
- U.S. sites
- 43
- U.S. states
- 22
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Comprehensive Integrated Care | Gilbert | Arizona | 85233 | — |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| St. Helena Hospital | Deer Park | California | 94574 | — |
| Mission Cardiovascular Research Institute | Fremont | California | 94538 | — |
| UCSF Fresno | Fresno | California | 93701 | — |
| St. Joseph Hospital | Orange | California | 92868 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Manatee Memorial Hospital | Bradenton | Florida | 34208 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32218 | — |
| Palm Vascular Centers | Miami Beach | Florida | 33140 | — |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | — |
| Via Christi Regional Medical Center - St. Francis Campus | Wichita | Kansas | 67226 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | — |
| St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | — |
| Charlton Memorial Hospital | Russells Mills | Massachusetts | 02720 | — |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | — |
| Deborah Heart & Lung Center | Browns Mills | New Jersey | 08015 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Vascular Institute of Atlantic Medical Imaging | Pomona | New Jersey | 08240 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | 10032 | — |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10065 | — |
| James J. Peters VA Medical Center | The Bronx | New York | 10468 | — |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | — |
| The Lindner Center | Cincinnati | Ohio | 45255 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ascension St. John Jane Phillips | Bartlesville | Oklahoma | 74006 | — |
| Lankenau Institute for Medical Research | Bryn Mawr | Pennsylvania | 19096 | — |
| Saint Vincent Consultants in Cardiovascular Diseases | Erie | Pennsylvania | 16502 | — |
| Pinnacle Health System | Wormleysburg | Pennsylvania | 17043 | — |
| Anmed Health | Anderson | South Carolina | 29621 | — |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Baylor All Saints Medical Center at Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Tech University Health Sciences Center at Lubbock | Lubbock | Texas | 79430 | — |
| San Antonio Vascular and Endovascular Clinic | San Antonio | Texas | 78221 | — |
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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04227899, 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 Dec 30, 2025 · Synced Oct 27, 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 public registry record, listed eligibility criteria, and available contact information for NCT04227899 live on ClinicalTrials.gov.