Clinical trial NCT06656364: Esprit BTK Post-Approval Study
Official title: Esprit BTK Post-Approval Study (Esprit BTK PAS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Limb-Threatening Ischemia
Keywords: ABT-CIP-10519
Esprit BTK System
Infrapopliteal lesions
Post-approval study
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR)
timeFrame: At 1 year
measure: Primary Safety Endpoint(s):MALE at 6 months + POD at 30 days (Major Adverse Limb Event + Peri-Operative Death)
timeFrame: 6 months + 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 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
measure: Amputation (minor, major)
timeFrame: 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
measure: Amputation-free survival
timeFrame: 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
measure: Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) progression over time
timeFrame: 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
measure: Rutherford Becker category evolution over time
timeFrame: 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
measure: Wound healing, as assessed by investigator
timeFrame: 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
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular Clinical Research
state: Arizona
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Pleasanton
country: United States
facility: Stanford ValleyCare
state: California
city: Thorton
country: United States
facility: ClinRe 001-001
state: Colorado
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: St. Augustine
country: United States
facility: Ansaarie Cardiac and Endovascular Center of Excellence
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Atlanta
country: United States
facility: Grady Clinical Research Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Thomasville
country: United States
facility: Archbold Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Fall River
country: United States
facility: Charlton Memorial Hospital
state: Massachusetts
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Cornell University
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital - North
state: New York
city: Asheville
country: United States
facility: Mission Health & Hospitals
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Bartlesville
country: United States
facility: Ascension St. John Jane Phillips
state: Oklahoma
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Chattanooga
country: United States
facility: Parkridge Medical Center
state: Tennessee
city: Johnson City
country: United States
facility: Johnson City Medical Center Hospital
state: Tennessee
city: Abilene
country: United States
facility: Hendrick Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center at Fort Worth
state: Texas
city: Houston
country: United States
facility: Park Plaza Hospital
state: Texas
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Nedlands
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
state: Hk Sar
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Sharjah
country: United Arab Emirates
facility: Al Qassimi Hospital
Study officials:
affiliation: Prince of Wales Private Hospital, Randwick, NSW, Australia
name: Ramon L Varcoe, MBBS, MS, FRACS, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Hospital, New York, NY
name: Sahil Parikh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian/Cornell, New York, NY
name: Brian G Derubertis, MD
role: PRINCIPAL_INVESTIGATOR
References: