Esprit BTK Post-Approval Study
EspritBTKPAS
1 other identifier
interventional
200
4 countries
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2024
CompletedStudy Start
First participant enrolled
October 21, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2029
March 25, 2026
March 1, 2026
2.5 years
October 15, 2024
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR)
This effectiveness endpoint was chosen because it allows to assess whether Esprit BTK is effective at maintaining patency (CD-TLR).
At 1 year
Primary Safety Endpoint(s):MALE at 6 months + POD at 30 days (Major Adverse Limb Event + Peri-Operative Death)
This safety endpoint was chosen because it is a commonly used endpoint to assess the safety of devices used in lower limb treatment, including treatment of lesions below the knee. Additionally, this endpoint assesses whether the device is associated with acute and sub-acute harm such as death and limb loss.
6 months + 30 days
Secondary Outcomes (6)
All-cause mortality
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Amputation (minor, major)
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Amputation-free survival
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) progression over time
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Rutherford Becker category evolution over time
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
- +1 more secondary outcomes
Study Arms (1)
Esprit BTK System
EXPERIMENTALThis device, manufactured by Abbott Medical, is intended to be used for improving luminal diameter in infrapopliteal lesions in patients with CLTI.
Interventions
The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.
Eligibility Criteria
You may qualify if:
- Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site.
- Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
- Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
- Subject must be at least 18 years of age.
- Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
- Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm.
- Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels.
You may not qualify if:
- Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
- Subject is currently participating in another clinical investigation that has not yet completed its primary endpoint.
- Subject or Legally Acceptable Representative (LAR) is unable or unwilling to provide written consent prior to enrollment.
- Subject with life expectancy ≤ 1 year.
- Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation.
- Subject has in-stent restenosis in the target vessel or requires a metallic stent as part of a planned treatment or a bailout in the target vessel during the index procedure.
- Subject had been previously treated with Esprit BTK Scaffold(s) within the past 30 days in the same vessel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
HonorHealth
Scottsdale, Arizona, 85258, United States
Pima Heart and Vascular Clinical Research
Tucson, Arizona, 85718, United States
UCSF Fresno
Fresno, California, 93720, United States
Good Samaritan Hospital
Los Angeles, California, 90017, United States
ClinRé 001-100 - Denver
Denver, Colorado, 80220, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
Ansaarie Cardiac and Endovascular Center of Excellence
Saint Augustine, Florida, 32080, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
Grady Clinical Research Center
Atlanta, Georgia, 30303, United States
Cardiovascular Consultants of South Georgia, LLC
Thomasville, Georgia, 31792, United States
SIU School of Medicine
Springfield, Illinois, 62794, United States
St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
Charlton Memorial Hospital
Fall River, Massachusetts, 02720, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Sorin Medical
New York, New York, 10005, United States
New York University Hospital
New York, New York, 10016, United States
NYU Langone Health
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10019, United States
New York Presbyterian Hospital-Cornell University
New York, New York, 10021, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Staten Island University Hospital - North
Staten Island, New York, 10305, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Christ Hospital
Cincinnati, Ohio, 45255, United States
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, 74006, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Johnson City Medical Center Hospital
Johnson City, Tennessee, 37604, United States
Hendrick Medical Center
Abilene, Texas, 79601, United States
Medical City Arlington
Arlington, Texas, 76014, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104, United States
HCA Houston Healthcare Medical Center
Houston, Texas, 77004, United States
Queen Mary Hospital
Hong Kong, HK SAR, 999077, Hong Kong
Auckland City Hospital
Auckland, 1003, New Zealand
Al Qassimi Hospital
Sharjah city, Emirate of Sharjah, 3500, United Arab Emirates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramon L Varcoe, MBBS, MS, FRACS, PHD
Prince of Wales Private Hospital, Randwick, NSW, Australia
- PRINCIPAL INVESTIGATOR
Sahil Parikh, MD
New York Presbyterian Hospital, New York, NY
- PRINCIPAL INVESTIGATOR
Brian G Derubertis, MD
New York Presbyterian/Cornell, New York, NY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2024
First Posted
October 24, 2024
Study Start
October 21, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
May 30, 2029
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share