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Esprit BTK Post-Approval Study
Sponsor: Abbott Medical Devices
Summary
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.
Official title: Esprit BTK Post-Approval Study (Esprit BTK PAS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-10-21
Completion Date
2029-05-30
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Esprit BTK System
The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.
Locations (39)
HonorHealth
Scottsdale, Arizona, United States
Pima Heart and Vascular Clinical Research
Tucson, Arizona, United States
UCSF Fresno
Fresno, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
ClinRé 001-100 - Denver
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Ansaarie Cardiac and Endovascular Center of Excellence
Saint Augustine, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Grady Clinical Research Center
Atlanta, Georgia, United States
Cardiovascular Consultants of South Georgia, LLC
Thomasville, Georgia, United States
SIU School of Medicine
Springfield, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Charlton Memorial Hospital
Fall River, Massachusetts, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Sorin Medical
New York, New York, United States
New York University Hospital
New York, New York, United States
NYU Langone Health
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian Hospital-Cornell University
New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Staten Island University Hospital - North
Staten Island, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Johnson City Medical Center Hospital
Johnson City, Tennessee, United States
Hendrick Medical Center
Abilene, Texas, United States
Medical City Arlington
Arlington, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, United States
HCA Houston Healthcare Medical Center
Houston, Texas, United States
Queen Mary Hospital
Hong Kong, HK SAR, Hong Kong
Auckland City Hospital
Auckland, New Zealand
Al Qassimi Hospital
Sharjah city, Emirate of Sharjah, United Arab Emirates