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NCT Number: NCT06807099

WRAP North America

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.

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Key information

Conditions

Venous Stenosis Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations Venous Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network, Toronto, Ontario, Canada

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)

Device

Target Lesion treated with WRAPSODY CIE

Primary outcomes

  1. Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)

    Time frame: 6 months

    The proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 months.

    Target Lesion Primary Patency (TLPP) defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.

  2. Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)

    Time frame: 30 days

    Proportions of subjects without any localized or systematic safety events through 30 days post-procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including CD-TLR or target lesion thrombosis)

Secondary outcomes

  1. Proportion of subjects with Target Lesion Primary Patency

    Time frame: 12, 24 and 36 months

    Proportion of subjects with Target Lesion Primary Patency at months 12, 24 and 36.

  2. Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)

    Time frame: 6, 12, 24 and 36 months

    Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)

  3. Proportion of subjects with Access Circuit Primary Patency (ACPP)

    Time frame: 6, 12, 24 and 36 months

    Proportion of subjects with Access Circuit Primary Patency (ACPP)

  4. Rates of procedure- and device-related adverse events

    Time frame: Index procedure, 30 days, 6, 12, 24 and 36 months

    Number of subjects with procedure- and device-related adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Coughlin

CONTACT

[email protected]

+1-385-766-9133

Vicky Brunk, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Feb 4, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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