NCT06807099 · Merit Medical Systems, Inc.
WRAP North America
What this study is about
The goal of this observational study is to investigate the safety and effectiveness 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 the usual treatment up to 3-years post-procedure.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Dothan, Alabama
- Phoenix, Arizona
- Riverside, California
- Jacksonville, Florida
- Sarasota, Florida
- Lexington, Kentucky
- Providence, Rhode Island
- Charleston, South Carolina
- Orangeburg, South Carolina
- Spartanburg, South Carolina
- Memphis, Tennessee
- Fort Worth, Texas
And 3 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations