Esprit BTK Post-Approval Study
- Conditions
- Chronic Limb-Threatening Ischemia
- Registration Number
- NCT06656364
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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General Inclusion Criteria
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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.
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Subject must be at least 18 years of age.
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Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
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Anatomic Inclusion Criteria
- 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.
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General Exclusion Criteria
- Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
- Subject is currently participating in another clinical investigation.
- Subject 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.
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Anatomic Exclusion Criteria
- Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure.
- Subject had been previously treated with Esprit BTK Scaffold(s).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR) At 1 year This effectiveness endpoint was chosen because it allows to assess whether Esprit BTK is effective at maintaining patency (CD-TLR).
Primary Safety Endpoint(s):MALE at 6 months + POD at 30 days (Major Adverse Limb Event + Peri-Operative Death) 6 months + 30 days 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.
- Secondary Outcome Measures
Name Time Method 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 Wound healing, as assessed by investigator 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
Trial Locations
- Locations (44)
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
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Stanford ValleyCare
🇺🇸Pleasanton, California, United States
ClinRe 001-001
🇺🇸Thorton, 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
🇺🇸St. Augustine, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Grady Clinical Research Center
🇺🇸Atlanta, Georgia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Archbold Medical Center
🇺🇸Thomasville, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, 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
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
New York University Hospital
🇺🇸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
Parkridge Medical Center
🇺🇸Chattanooga, Tennessee, United States
Johnson City Medical Center Hospital
🇺🇸Johnson City, Tennessee, United States
Hendrick Medical Center
🇺🇸Abilene, 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
Park Plaza Hospital
🇺🇸Houston, Texas, United States
Royal Perth Hospital
🇦🇺Perth, Nedlands, Australia
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Queen Mary Hospital
🇭🇰Hong Kong, Hk Sar, Hong Kong
Auckland City Hospital
🇳🇿Auckland, New Zealand
Al Qassimi Hospital
🇦🇪Sharjah, United Arab Emirates