RECRUITING

Esprit BTK Post-Approval Study

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Conditions

Chronic Limb-Threatening IschemiaABT-CIP-10519Esprit BTK SystemInfrapopliteal lesionsPost-approval study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Esprit BTK Post-Approval Study (Esprit BTK PAS)

Quick Facts

Study Start:2024-10-21
Study Completion:2029-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06656364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * General Inclusion Criteria
  2. 1. Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site.
  3. 1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
  4. 2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
  5. 2. Subject must be at least 18 years of age.
  6. 3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
  7. * Anatomic Inclusion Criteria
  8. 1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm.
  9. 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.
  1. * General Exclusion Criteria
  2. 1. Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
  3. 2. Subject is currently participating in another clinical investigation.
  4. 3. Subject is unable or unwilling to provide written consent prior to enrollment.
  5. 4. Subject with life expectancy ≤ 1 year.
  6. 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.
  7. * Anatomic Exclusion Criteria
  8. 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.
  9. 2. Subject had been previously treated with Esprit BTK Scaffold(s).

Contacts and Locations

Study Contact

Rebecca Maslow
CONTACT
+1 612 356 6169
rebecca.maslow@abbott.com
Karine Ruster
CONTACT
+1 (408) 845-0764
karine.piard-ruster@abbott.com

Principal Investigator

Ramon L Varcoe, MBBS, MS, FRACS, PHD
PRINCIPAL_INVESTIGATOR
Prince of Wales Private Hospital, Randwick, NSW, Australia
Sahil Parikh, MD
PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital, New York, NY
Brian G Derubertis, MD
PRINCIPAL_INVESTIGATOR
New York Presbyterian/Cornell, New York, NY

Study Locations (Sites)

HonorHealth
Scottsdale, Arizona, 85258
United States
UCSF Fresno
Fresno, California, 93701
United States
Good Samaritan Hospital
Los Angeles, California, 90017
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
ClinRe 001-001
Thorton, Colorado, 80023
United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
United States
Ansaarie Cardiac and Endovascular Center of Excellence
St. Augustine, Florida, 32080
United States
Tallahassee Research Institute
Tallahassee, Florida, 32308
United States
Grady Clinical Research Center
Atlanta, Georgia, 30303
United States
University of Chicago
Chicago, Illinois, 60637
United States
SIU School of Medicine
Springfield, Illinois, 62794
United States
St. Vincent Hospital
Indianapolis, Indiana, 46260
United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, 67214
United States
Charlton Memorial Hospital
Fall River, Massachusetts, 02720
United States
Jackson Heart Clinic
Jackson, Mississippi, 39216
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
St. Luke's Hospital
Kansas City, Missouri, 64111
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
New York University Hospital
New York, New York, 10016
United States
New York Presbyterian Hospital-Cornell University
New York, New York, 10021
United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
Staten Island University Hospital - North
Staten Island, New York, 10305
United States
Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Christ Hospital
Cincinnati, Ohio, 45255
United States
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, 74006
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
Hendrick Medical Center
Abilene, Texas, 79601
United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104
United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Ramon L Varcoe, MBBS, MS, FRACS, PHD, PRINCIPAL_INVESTIGATOR, Prince of Wales Private Hospital, Randwick, NSW, Australia
  • Sahil Parikh, MD, PRINCIPAL_INVESTIGATOR, New York Presbyterian Hospital, New York, NY
  • Brian G Derubertis, MD, PRINCIPAL_INVESTIGATOR, New York Presbyterian/Cornell, New York, NY

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21
Study Completion Date2029-05-30

Study Record Updates

Study Start Date2024-10-21
Study Completion Date2029-05-30

Terms related to this study

Keywords Provided by Researchers

  • ABT-CIP-10519
  • Esprit BTK System
  • Infrapopliteal lesions
  • Post-approval study

Additional Relevant MeSH Terms

  • Chronic Limb-Threatening Ischemia