Recruiting

WRAPSODY CIE

Sponsor:

Merit Medical Systems, Inc.

Code:

NCT06807099

Conditions

Venous Stenosis

Venous Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)

Study Details

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

Study ID

NCT06807099

Start date

Jul 31, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Interventions

Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)

Target Lesion treated with WRAPSODY CIE

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Irene Coughlin

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

Vicky Brunk, RN

WRAP-NA@merit.com

Locations

Trinity Research Group

Recruiting

Dothan, Alabama, United States, 36301

Principal Investigator:

Jason Beaver, MD

AKDHC Phoenix Surgery Center

Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator:

Shouwen Wang, MD

Apex Research of Riverside

Recruiting

Riverside, California, United States, 92505

Principal Investigator:

Dalia Dawoud, MD

American Access Care of Jacksonville

Recruiting

Jacksonville, Florida, United States, 32218

Principal Investigator:

Rishi Razdan, MD

Sarasota Memorial Research Institute

Recruiting

Sarasota, Florida, United States, 34239

Principal Investigator:

Jason Wagner, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

Sayee Alagusundaramoorthy, MD

American Access Care of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02906

Principal Investigator:

Jonah Licht, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Adam Tanious, MD

Medical University of South Carolina

Recruiting

Orangeburg, South Carolina, United States, 29118

Principal Investigator:

Mark London, MD

Spartanburg Medical System

Recruiting

Spartanburg, South Carolina, United States, 29303

Principal Investigator:

Ari Kramer, MD

Texas Research Institute

Recruiting

Fort Worth, Texas, United States, 76104

Principal Investigator:

Saravanan Balamuthusamy, MD

Humble Vascular Surgical Center

Recruiting

Humble, Texas, United States, 77338

Principal Investigator:

Ruchdi Barakat, MD

Sentara Vascular Specialists

Recruiting

Virginia Beach, Virginia, United States, 23507

Principal Investigator:

David Dexter, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Dheeraj Rajan, MD

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Principal Investigator:

Alexis Valin-Doyon, MD

More Information

Sponsor

Merit Medical Systems, Inc.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merit Medical Systems, Inc. on 2026-08-26.