WRAP North America

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Stenosis; Venous Occlusion
• Intervention / Treatment: Device: Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)

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)

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Irene Coughlin; Phone Number: +1-385-766-9133; Email: irene.coughlin@merit.com
• Study Contact Backup: Name: Vicky Brunk, RN; Email: WRAP-NA@merit.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • University Health Network
      • Principal Investigator: Dheeraj Rajan, MD
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Recruiting
      • Trinity Research Group
      • Principal Investigator: Jason Beaver, MD
  • Florida
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Research Institute
      • Principal Investigator: Jason Wagner, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University Of Kentucky
      • Principal Investigator: Sayee Alagusundaramoorthy, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Adam Tanious, MD
    • Orangeburg, South Carolina, United States, 29118
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Mark London, MD
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Medical System
      • Principal Investigator: Ari Kramer, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Recruiting
      • Bluff City Vascular
      • Principal Investigator: Omar Davis, MD
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Texas Research Institute
      • Principal Investigator: Saravanan Balamuthusamy, MD
    • Humble, Texas, United States, 77338
      • Recruiting
      • Humble Vascular Surgical Center
      • Principal Investigator: Ruchdi Barakat, MD
    • San Antonio, Texas, United States, 78216
      • Recruiting
      • San Antonio Kidney Disease Center
      • Principal Investigator: Rajeev Narayan, MD
  • Virginia
    • Virginia Beach, Virginia, United States, 23507
      • Recruiting
      • Sentara Vascular Specialists
      • Principal Investigator: David Dexter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with Target Lesion Primary Patency	Proportion of subjects with Target Lesion Primary Patency at months 12, 24 and 36.	12, 24 and 36 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)	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)	Proportion of subjects with Access Circuit Primary Patency (ACPP)	6, 12, 24 and 36 months
Rates of procedure- and device-related adverse events	Number of subjects with procedure- and device-related adverse events	Index procedure, 30 days, 6, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Arteriovenous Fistula (AVF); Arteriovenous Graft (AVG); AV fistula; AV graft
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Arteriovenous Fistula
• Other Study ID Numbers: CVO-P4-25-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No