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Recruiting NCT06807099

WRAP North America

— Observational Venous Stenosis Venous Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE).
Who it may be relevant to
Registry conditions: Venous Stenosis, Venous Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

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.

Detailed description

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)

Interventions

  • Device Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
    Target Lesion treated with WRAPSODY CIE

Primary outcome measures

  • Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint) [Time frame: 6 months]
  • Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint) [Time frame: 30 days]
Secondary outcome measures (4)
  • Proportion of subjects with Target Lesion Primary Patency [Time frame: 12, 24 and 36 months]
  • Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) [Time frame: 6, 12, 24 and 36 months]
  • Proportion of subjects with Access Circuit Primary Patency (ACPP) [Time frame: 6, 12, 24 and 36 months]
  • Rates of procedure- and device-related adverse events [Time frame: Index procedure, 30 days, 6, 12, 24 and 36 months]

Eligibility criteria

Inclusion criteria

  • Subject provides written informed consent for study participation.
  • Subject is male or female, with an age ≥ 18 years at date of enrollment.
  • Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.
  • Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.
  • The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
  • Subject has stenosis or occlusion within the dialysis outflow circuit and is treated with WRAPSODY CIE in accordance with device instructions for use.

Exclusion criteria

  • Subject has a planned surgical revision of access site.
  • Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
  • Subject has an uncorrectable coagulation disorder.
  • Known hypersensitivity to nickel or titanium.
  • Subject's hemodialysis access is anticipated to be abandoned within 6 months.
  • Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
  • Full expansion of a PTA balloon cannot be achieved during predilatation.
  • Device would be placed in the Superior Vena Cava
  • Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 15 centers
  • Trinity Research Group — Dothan
  • AKDHC Phoenix Surgery Center — Phoenix
  • Apex Research of Riverside — Riverside
  • American Access Care of Jacksonville — Jacksonville
  • Sarasota Memorial Research Institute — Sarasota
  • University of Kentucky — Lexington
  • American Access Care of Rhode Island — Providence
  • Medical University of South Carolina — Charleston
  • … and 7 more centers
Canada · 1 center
  • University Health Network — Toronto

Identifiers

NCT: NCT06807099 · CVO-P4-25-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗