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Active, not recruiting Not applicable Interventional Results available

LIFE-BTK Randomized Controlled Trial

ClinicalTrials.gov ID: NCT04227899

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.

ClinicalTrials.gov public records Last synced May 18, 2026, 4:32 AM EDT

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

Study identification

NCT ID
NCT04227899
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Abbott Medical Devices
Industry
Enrollment
261 participants

Conditions and interventions

Interventions

  • Esprit BTK Device Device
  • Percutaneous Transluminal Angioplasty (PTA) Device Device

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 17, 2020
Primary completion
Aug 16, 2023
Completion
Jun 30, 2027
Last update posted
Dec 29, 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 29, 2025 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04227899 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →