RECRUITING

WRAP North America

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.

Conditions

Venous StenosisVenous Occlusion
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Related Conditions:

Venous StenosisVenous Occlusion

Study Overview

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Study Details

Study overview

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.

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)

WRAP North America

Condition
Venous Stenosis
Intervention / Treatment

-

Contacts and Locations

Orangeburg

Medical University of South Carolina, Orangeburg, South Carolina, United States, 29118

Memphis

Bluff City Vascular, Memphis, Tennessee, United States, 38104

Fort Worth

Texas Research Institute, Fort Worth, Texas, United States, 76104

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merit Medical Systems, Inc.,

Study Record Dates

2030-07