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 Genders
- 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
Good Samaritan Hospital
Los Angeles, California 90017
Los Angeles, California 90017
First Coast Cardiovascular Institute
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Ansaarie Cardiac and Endovascular Center of Excellence
St. Augustine, Florida 32080
St. Augustine, Florida 32080
St. Vincent Hospital
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Charlton Memorial Hospital
Fall River, Massachusetts 02720
Fall River, Massachusetts 02720
North Mississippi Medical Center
Tupelo, Mississippi 38801
Tupelo, Mississippi 38801
New York University Hospital
New York, New York 10016
New York, New York 10016
Mount Sinai Hospital
New York, New York 10019
New York, New York 10019
New York Presbyterian Hospital-Cornell University
New York, New York 10021
New York, New York 10021
New York-Presbyterian/Columbia University Medical Center
New York, New York 10032
New York, New York 10032
St. Francis Hospital
Roslyn, New York 11576
Roslyn, New York 11576
Staten Island University Hospital - North
Staten Island, New York 10305
Staten Island, New York 10305
Ascension St. John Jane Phillips
Bartlesville, Oklahoma 74006
Bartlesville, Oklahoma 74006
Erlanger Medical Center
Chattanooga, Tennessee 37403
Chattanooga, Tennessee 37403
Contact:
Lorraine Christensen
Lorraine Christensen
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas 75390
Dallas, Texas 75390
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
More Details
- NCT ID
- NCT06656364
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices