Venous StenosisNCT06807099
WRAP North America
An observational study of Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc. at 16 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stenosis, Venous Occlusion
- What is being tested?
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 31 Jul 2025to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Vicky Brunk, RN contact
16 sites in 2 countries
United States14 sites, 13 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Adam Tanious, MD
- Recruiting
Trinity Research Group
Dothan, Alabama, 36301
Jason Beaver, MD
- Recruiting
Texas Research Institute
Fort Worth, Texas, 76104
Saravanan Balamuthusamy, MD
- Recruiting
Humble Vascular Surgical Center
Humble, Texas, 77338
Ruchdi Barakat, MD
- Recruiting
American Access Care of Jacksonville
Jacksonville, Florida, 32218
Rishi Razdan, MD
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Sayee Alagusundaramoorthy, MD
- Active, not recruiting
Bluff City Vascular
Memphis, Tennessee, 38104
- Recruiting
Medical University of South Carolina
Orangeburg, South Carolina, 29118
Mark London, MD
- Recruiting
AKDHC Phoenix Surgery Center
Phoenix, Arizona, 85016
Shouwen Wang, MD
- Recruiting
American Access Care of Rhode Island
Providence, Rhode Island, 02906
Jonah Licht, MD
- Recruiting
Apex Research of Riverside
Riverside, California, 92505
Dalia Dawoud, MD
- Recruiting
Sarasota Memorial Research Institute
Sarasota, Florida, 34239
Jason Wagner, MD
- Recruiting
Spartanburg Medical System
Spartanburg, South Carolina, 29303
Ari Kramer, MD
- Recruiting
Sentara Vascular Specialists
Virginia Beach, Virginia, 23507
David Dexter, MD
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Alexis Valin-Doyon, MD
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Dheeraj Rajan, MD
About this study
Official 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)
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.
Read the 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)
- Conditions
- Venous Stenosis, Venous Occlusion
- Being tested
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
- Keywords
- Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG), AV fistula, AV graft
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)Device
Target Lesion treated with WRAPSODY CIE
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 30 days
Secondary outcomes (4)
Proportion of subjects with Target Lesion Primary Patency
Proportion of subjects with Target Lesion Primary Patency at months 12, 24 and 36.
Measured: 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)
Measured: 6, 12, 24 and 36 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Measured: 6, 12, 24 and 36 months
Rates of procedure- and device-related adverse events
Number of subjects with procedure- and device-related adverse events
Measured: Index procedure, 30 days, 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start31 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807099
- Sponsor's protocol ID
- CVO-P4-25-01
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06807099
- Acronym / sponsor ID
- CVO-P4-25-01
- Conditions
- Venous Stenosis, Venous Occlusion
- Keywords
- Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG), AV fistula, AV graft
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)Target Lesion treated with WRAPSODY CIE | Device | – |
Primary outcome
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.
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)
4 secondary outcomes
Proportion of subjects with Target Lesion Primary Patency
Time frame: 12, 24 and 36 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 6, 12, 24 and 36 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time frame: 6, 12, 24 and 36 months
Rates of procedure- and device-related adverse events
Time frame: Index procedure, 30 days, 6, 12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vicky Brunk, RN contact
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Coughlin (+1-385-766-9133, irene.coughlin@merit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.