Esprit BTK Post-Approval Study (EspritBTKPAS)

Esprit BTK Post-Approval Study (Esprit BTK PAS)

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 Overview

• Status: Active, not recruiting
• Conditions: Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Device: Esprit BTK System

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • HK SAR
    • Hong Kong, HK SAR, Hong Kong, 999077
      • Queen Mary Hospital
• New Zealand
  • Auckland, New Zealand, 1003
    • Auckland City Hospital
• United Arab Emirates
  • Emirate of Sharjah
    • Sharjah city, Emirate of Sharjah, United Arab Emirates, 3500
      • Al Qassimi Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
    • Tucson, Arizona, United States, 85718
      • Pima Heart and Vascular Clinical Research
  • California
    • Fresno, California, United States, 93720
      • UCSF Fresno
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
  • Colorado
    • Denver, Colorado, United States, 80220
      • ClinRé 001-100 - Denver
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32256
      • First Coast Cardiovascular Institute
    • Saint Augustine, Florida, United States, 32080
      • Ansaarie Cardiac and Endovascular Center of Excellence
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Clinical Research Center
    • Thomasville, Georgia, United States, 31792
      • Cardiovascular Consultants of South Georgia, LLC
  • Illinois
    • Springfield, Illinois, United States, 62794
      • SIU School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Charlton Memorial Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10016
      • New York University Hospital
    • New York, New York, United States, 10032
      • New York-Presbyterian/Columbia University Medical Center
    • New York, New York, United States, 10019
      • Mount Sinai Hospital
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital-Cornell University
    • New York, New York, United States, 10005
      • Sorin Medical
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital - North
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • Christ Hospital
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Ascension St. John Jane Phillips
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
    • Johnson City, Tennessee, United States, 37604
      • Johnson City Medical Center Hospital
  • Texas
    • Abilene, Texas, United States, 79601
      • Hendrick Medical Center
    • Arlington, Texas, United States, 76014
      • Medical City Arlington
    • Dallas, Texas, United States, 75390
      • University Of Texas Southwestern Medical Center At Dallas
    • Fort Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center at Fort Worth
    • Houston, Texas, United States, 77004
      • HCA Houston Healthcare Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 that has not yet completed its primary endpoint.
  3. Subject or Legally Acceptable Representative (LAR) 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 a metallic stent as part of a planned treatment or a bailout in the target vessel during the index procedure.
  2. Subject had been previously treated with Esprit BTK Scaffold(s) within the past 30 days in the same vessel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Esprit BTK System; The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	6 months + 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death was classified according to the underlying cause. Death within 30 days of the study procedure was classified as procedure-related unless medical history or autopsy findings demonstrated otherwise. Cardiac death: Any death due to a proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death, or death of unknown cause. Vascular death: Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. Non-cardiovascular death: Any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma.	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)	The definition of amputation applied only to amputations of the limb that was treated. Minor amputation referred to toe amputation(s), ray amputation(s) limited to the metatarsal head and distal half of the metatarsal bone, and trans-metatarsal amputation. Major amputation was defined as limb loss at or proximal to the transtibial level. Major amputations were specified as below-the-knee and above-the-knee amputations.	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	Freedom from above-ankle amputation in the treated limb and death	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	The ABI was the ratio of the ankle to arm pressure, and it was calculated by dividing the systolic blood pressure in the ankle of one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9-1.4 was considered within the normal range. A reduced ABI (less than 0.9) was consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and values below 0.5 indicating severe disease. A value greater than 1.4 was considered abnormal, suggesting calcification of the arterial walls and noncompressible vessels, reflecting severe peripheral vascular disease.	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	The Rutherford Becker classification was defined as follows: Grade I (0) Asymptomatic, no hemodynamically significant occlusive disease. (1)Mild claudication. (2) Moderate claudication. (3) Severe claudication. Grade II (4)Ischemic rest pain. Grade III(5) Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia. (6) Major tissue loss extending above the transmetatarsal level, where the functional foot was no longer salvageable.	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	An index wound healing assessment log was required only for subjects who had a wound on the index limb at the time of the index procedure. This was intended to allow the healing of the index wound after treatment to be documented. All subjects that had a wound at the time of the index procedure are required to have an assessment by the site at each follow-up visit even if the index wound was healed at the previous visit. This will confirm that the index wound remains healed. If the index wound at the same location following healing has re-opened, the wound should still be assessed in the same index wound log.	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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Ramon L Varcoe, MBBS, MS, FRACS, PHD, Prince of Wales Private Hospital, Randwick, NSW, Australia; Principal Investigator: Sahil Parikh, MD, New York Presbyterian Hospital, New York, NY; Principal Investigator: Brian G Derubertis, MD, New York Presbyterian/Cornell, New York, NY

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2029

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Infrapopliteal lesions; ABT-CIP-10519; Esprit BTK System; Post-approval study
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: ABT-CIP-10519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes