RECRUITING

WRAP North America

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 goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population. Participants treated with the WRAPSODY CIE device in accordance with the device instructions for use will be followed in accordance with standard of care up to 3-years post-procedure.

Official Title

Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit (WRAP North America)

Quick Facts

Study Start:2025-07-31
Study Completion:2030-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06807099

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. 1. Subject provides written informed consent for study participation.
  2. 2. Subject is male or female, with an age ≥ 18 years at date of enrollment.
  3. 3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.
  4. 4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.
  5. 5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
  6. 6. Subject has stenosis or occlusion within the dialysis outflow circuit and is treated with WRAPSODY CIE in accordance with device instructions for use.
  1. 1. Subject has a planned surgical revision of access site.
  2. 2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
  3. 3. Subject has an uncorrectable coagulation disorder.
  4. 4. Known hypersensitivity to nickel or titanium.
  5. 5. Subject's hemodialysis access is anticipated to be abandoned within 6 months.
  6. 6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
  7. 7. Full expansion of a PTA balloon cannot be achieved during predilatation.
  8. 8. Device would be placed in the Superior Vena Cava
  9. 9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

Contacts and Locations

Study Contact

Irene Coughlin
CONTACT
+1-385-766-9133
irene.coughlin@merit.com
Vicky Brunk, RN
CONTACT
WRAP-NA@merit.com

Study Locations (Sites)

Medical University of South Carolina
Orangeburg, South Carolina, 29118
United States
Bluff City Vascular
Memphis, Tennessee, 38104
United States
Texas Research Institute
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: Merit Medical Systems, Inc.

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 Date2025-07-31
Study Completion Date2030-07

Study Record Updates

Study Start Date2025-07-31
Study Completion Date2030-07

Terms related to this study

Keywords Provided by Researchers

  • Arteriovenous Fistula (AVF)
  • Arteriovenous Graft (AVG)
  • AV fistula
  • AV graft

Additional Relevant MeSH Terms

  • Venous Stenosis
  • Venous Occlusion