WRAP North America

NCT06807099 | Recruiting

• 1 other identifier: CVO-P4-25-01
• Study Type: observational
• Target: 250
• Locations: 2 countries
• Sites: 12

Brief Summary

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 Stenosis; Venous Occlusion

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  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.

  6 months

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

  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)

  30 days

Secondary Outcomes (4)

• Proportion of subjects with Target Lesion Primary Patency

  12, 24 and 36 months

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

  6, 12, 24 and 36 months

• Proportion of subjects with Access Circuit Primary Patency (ACPP)

  6, 12, 24 and 36 months

• Rates of procedure- and device-related adverse events

  Index procedure, 30 days, 6, 12, 24 and 36 months

Interventions

Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE) DEVICE

Target Lesion treated with WRAPSODY CIE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with stenosis or occlusion within the dialysis outflow circuit who meet the inclusion and exclusion criteria are intended to participate in this study. The eligibility criteria are kept to a minimum to better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases or anatomies.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (12)

Trinity Research Group

Dothan, Alabama, 36301, United States

RECRUITING

Sarasota Memorial Research Institute

Sarasota, Florida, 34239, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Medical University of South Carolina

Orangeburg, South Carolina, 29118, United States

RECRUITING

Spartanburg Medical System

Spartanburg, South Carolina, 29303, United States

RECRUITING

Bluff City Vascular

Memphis, Tennessee, 38104, United States

RECRUITING

Texas Research Institute

Fort Worth, Texas, 76104, United States

RECRUITING

Humble Vascular Surgical Center

Humble, Texas, 77338, United States

RECRUITING

San Antonio Kidney Disease Center

San Antonio, Texas, 78216, United States

RECRUITING

Sentara Vascular Specialists

Virginia Beach, Virginia, 23507, United States

RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Irene Coughlin

CONTACT

+1-385-766-9133; irene.coughlin@merit.com

Vicky Brunk, RN

CONTACT

WRAP-NA@merit.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (11)