Esprit BTK Post-Approval Study
Purpose
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.
Condition
- Chronic Limb-Threatening Ischemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- General Inclusion Criteria 1. Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site. 1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first. 2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements. 2. Subject must be at least 18 years of age. 3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions. - Anatomic Inclusion Criteria 1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm. 2. 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.
Exclusion Criteria
- General Exclusion Criteria 1. Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU). 2. Subject is currently participating in another clinical investigation. 3. Subject is unable or unwilling to provide written consent prior to enrollment. 4. Subject with life expectancy ≤ 1 year. 5. 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. - Anatomic Exclusion Criteria 1. Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure. 2. Subject had been previously treated with Esprit BTK Scaffold(s).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Esprit BTK System |
This device, manufactured by Abbott Medical, is intended to be used for improving luminal diameter in infrapopliteal lesions in patients with CLTI. |
|
Recruiting Locations
HonorHealth
Scottsdale 5313457, Arizona 5551752 85258
Scottsdale 5313457, Arizona 5551752 85258
Pima Heart and Vascular Clinical Research
Tucson 5318313, Arizona 5551752 85718
Tucson 5318313, Arizona 5551752 85718
Good Samaritan Hospital
Los Angeles 5368361, California 5332921 90017
Los Angeles 5368361, California 5332921 90017
Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Washington D.C. 4140963, District of Columbia 4138106 20010
First Coast Cardiovascular Institute
Jacksonville 4160021, Florida 4155751 32256
Jacksonville 4160021, Florida 4155751 32256
Ansaarie Cardiac and Endovascular Center of Excellence
Saint Augustine 4170894, Florida 4155751 32080
Saint Augustine 4170894, Florida 4155751 32080
Tallahassee Research Institute
Tallahassee 4174715, Florida 4155751 32308
Tallahassee 4174715, Florida 4155751 32308
Grady Clinical Research Center
Atlanta 4180439, Georgia 4197000 30303
Atlanta 4180439, Georgia 4197000 30303
Archbold Medical Center
Thomasville 4226348, Georgia 4197000 31792
Thomasville 4226348, Georgia 4197000 31792
SIU School of Medicine
Springfield 4250542, Illinois 4896861 62794
Springfield 4250542, Illinois 4896861 62794
St. Vincent Hospital
Indianapolis 4259418, Indiana 4921868 46260
Indianapolis 4259418, Indiana 4921868 46260
Charlton Memorial Hospital
Fall River 4936159, Massachusetts 6254926 02720
Fall River 4936159, Massachusetts 6254926 02720
Jackson Heart Clinic
Jackson 4431410, Mississippi 4436296 39216
Jackson 4431410, Mississippi 4436296 39216
North Mississippi Medical Center
Tupelo 4448903, Mississippi 4436296 38801
Tupelo 4448903, Mississippi 4436296 38801
New York University Hospital
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
Mount Sinai Hospital
New York 5128581, New York 5128638 10019
New York 5128581, New York 5128638 10019
New York Presbyterian Hospital-Cornell University
New York 5128581, New York 5128638 10021
New York 5128581, New York 5128638 10021
New York-Presbyterian/Columbia University Medical Center
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
St. Francis Hospital
Roslyn 5134415, New York 5128638 11576
Roslyn 5134415, New York 5128638 11576
Staten Island University Hospital - North
Staten Island 5139568, New York 5128638 10305
Staten Island 5139568, New York 5128638 10305
Carolinas Medical Center
Charlotte 4460243, North Carolina 4482348 28203
Charlotte 4460243, North Carolina 4482348 28203
Christ Hospital
Cincinnati 4508722, Ohio 5165418 45255
Cincinnati 4508722, Ohio 5165418 45255
Ascension St. John Jane Phillips
Bartlesville 4529987, Oklahoma 4544379 74006
Bartlesville 4529987, Oklahoma 4544379 74006
Hightower Clinical
Oklahoma City 4544349, Oklahoma 4544379 73102
Oklahoma City 4544349, Oklahoma 4544379 73102
Oklahoma Heart Hospital
Oklahoma City 4544349, Oklahoma 4544379 73120
Oklahoma City 4544349, Oklahoma 4544379 73120
Erlanger Medical Center
Chattanooga 4612862, Tennessee 4662168 37403
Chattanooga 4612862, Tennessee 4662168 37403
Johnson City Medical Center Hospital
Johnson City 4633419, Tennessee 4662168 37604
Johnson City 4633419, Tennessee 4662168 37604
Hendrick Medical Center
Abilene 4669635, Texas 4736286 79601
Abilene 4669635, Texas 4736286 79601
University of Texas Southwestern Medical Center at Dallas
Dallas 4684888, Texas 4736286 75390
Dallas 4684888, Texas 4736286 75390
Baylor All Saints Medical Center at Fort Worth
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
Park Plaza Hospital
Houston 4699066, Texas 4736286 77004
Houston 4699066, Texas 4736286 77004
More Details
- NCT ID
- NCT06656364
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices