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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.
HonorHealth
Scottsdale, Arizona, United States
RECRUITINGPima Heart and Vascular Clinical Research
Tucson, Arizona, United States
RECRUITINGUCSF Fresno
Fresno, California, United States
RECRUITINGGood Samaritan Hospital
Los Angeles, California, United States
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).
Time frame: 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.
Time frame: 6 months + 30 days
All-cause mortality
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGFirst Coast Cardiovascular Institute
Jacksonville, Florida, United States
RECRUITINGAnsaarie Cardiac and Endovascular Center of Excellence
Saint Augustine, Florida, United States
RECRUITINGTallahassee Research Institute
Tallahassee, Florida, United States
RECRUITINGGrady Clinical Research Center
Atlanta, Georgia, United States
RECRUITINGArchbold Medical Center
Thomasville, Georgia, United States
RECRUITING...and 25 more locations