Venous StenosisNCT05062291
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
An observational study of Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc. at 35 sites in 9 countries.
Trial summary
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population. 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 Endovascular Stent Graft
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 35 sitesin 9 countries
- Study dates
- 23 Jun 2022to 19 Dec 2027
- 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: The registry will include peripheral cases in both AV graft and AV fistula patients (including at the graft vein anastomosis of an AVG patient) and thoracic central patients in both AV graft and AV fistula patients.
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 24 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 of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System 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 titanium alloy.
- 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.
Show all 9Show fewer
- Full expansion of a Percutaneous Transluminal Angioplasty (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
35 sites in 9 countries.
35 sites in 9 countries
Brazil14 sites
Hospital Felicio Rocho
Belo Horizonte
Afya Hospital
Brasília
Hospital Santa Lucia
Brasília
Hospital Vera Cruz
Campinas
Instituto Pro Renal
Curitiba
Complexo Hospitalar de Niterói
Niterói
Parana Medical Research Center
Paranã
Real Hospital Português de Beneficência em Pernambuco
Recife
Impar Servicos Hospitalares S/A - Hospital Sao Lucas
Rio de Janeiro
Rio de Janeiro State University
Rio de Janeiro
Hospital Da Bahia
Salvador
Centro Internacional de Pesquisa do Hospital Alemão Oswaldo Cruz
São Paulo
Hospital Santa Rita de Cassia
São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo
United Kingdom6 sites
Belfast City Hospital, Belfast Health and Social Care Trust
Belfast
Queen Elizabeth Hospital, University Hospital Birmingham
Birmingham
King's College Hospital, NHS Foundation Trust
London
Royal London Hospital, Barts Health NHS Trust
London
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford
Royal Berkshire NHS Foundation Trust
Reading
Australia5 sites
Monash Health
Clayton
Liverpool Hospital
Liverpool
Fiona Stanley Hospital
Murdoch
Sir Charles Gairdner Hospital
Nedlands
Princess Alexandra Hospital
Woolloongabba
New Zealand4 sites
Te Toka Tumai Auckland
Auckland
Te Whatu Ora Health NZ Waitemata
Auckland
Te Whatu Ora Health NZ Waitaha Canterbury
Christchurch
Te Whatu Ora Health New Zealand Waitemata
Hamilton
Germany2 sites
Protestant Hospital Queen Elisabeth Herzberge
Berlin
University of Cologne
Cologne
About this study
Official title: Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit of an Arteriovenous (AVF) Fistula or AV Graft (AVG) (The WRAP Registry)
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
Read the detailed description
Prospective, multicenter, observational study to evaluate the Merit WRAPSODY™ Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft (The WRAP Registry)
- Conditions
- Venous Stenosis, Venous Occlusion
- Being tested
- Merit WRAPSODY Endovascular Stent Graft
- 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 Endovascular Stent GraftDevice
Target Lesion Primary Patency (TLPP)
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)
Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is 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)
Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis).
Measured: 30 days
Secondary outcomes (4)
Proportion of subjects with Target Lesion Primary Patency
Proportion of subjects with Target Lesion Primary Patency
Measured: 12 and 24 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Measured: 6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Measured: 6, 12 and 24 months
Rates of procedure- and device-related adverse events
Rates of procedure- and device-related adverse events
Measured: Index procedure, 30 days, and months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start23 Jun 2022
- Primary completion6 May 2026
- Study completion19 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dheeraj Rajan, MD, Principal investigator, University of TorontoPanagiotis Kitrou, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062291
- Sponsor's protocol ID
- CVO-P4-21-01
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajan DK, Kitrou PM. Prospective, Multicenter, Observational Study to Evaluate a Cell-Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AV) Fistula or AV Graft (The WRAP Registry). Cardiovasc Intervent Radiol. 2023 Sep;46(9):1285-1291. doi: 10.1007/s00270-023-03531-w. Epub 2023 Aug 17.
PubMed 37592020
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 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™ Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit of an Arteriovenous (AVF) Fistula or AV Graft (AVG) (The WRAP Registry)
- ClinicalTrials.gov ID
- NCT05062291
- Acronym / sponsor ID
- CVO-P4-21-01
- Conditions
- Venous Stenosis, Venous Occlusion
- Keywords
- Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG), AV fistula, AV graft
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 19 Dec 2027 (estimated)
- First posted
- 30 Sep 2021 (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 WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
Detailed description
Prospective, multicenter, observational study to evaluate the Merit WRAPSODY™ Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft (The WRAP Registry)
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
- The registry will include peripheral cases in both AV graft and AV fistula patients (including at the graft vein anastomosis of an AVG patient) and thoracic central patients in both AV graft and AV fistula patients.
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 24 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 titanium alloy.
- 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 Endovascular Stent GraftTarget Lesion Primary Patency (TLPP) | Device | – |
Primary outcome
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
Time frame: 6 months
Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is 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
Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis).
4 secondary outcomes
Proportion of subjects with Target Lesion Primary Patency
Time frame: 12 and 24 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time frame: 6, 12 and 24 months
Rates of procedure- and device-related adverse events
Time frame: Index procedure, 30 days, and months 6
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 9 Oct 2026.
- Derived from this study: PubMed 37592020Rajan DK, Kitrou PM. Prospective, Multicenter, Observational Study to Evaluate a Cell-Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AV) Fistula or AV Graft (The WRAP Registry). Cardiovasc Intervent Radiol. 2023 Sep;46(9):1285-1291. doi: 10.1007/s00270-023-03531-w. Epub 2023 Aug 17.
- Individual participant dataSharing planned: No
Related trials for Venous Stenosis
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
RecruitingObservational study
Abbott Vascular Medical Device Registry
Acute Myocardial Infarction, Restenoses, Coronary
Recruiting
The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Venous Stenosis, Venous Occlusion
Recruiting
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
End Stage Renal Disease
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. This study is not recruiting at the moment.
Dheeraj Rajan, MD principal investigator
University of Toronto
Panagiotis Kitrou principal investigator
University Hospital of Patras
35 sites in 9 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 35 sites in 9 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Brazil, United Kingdom, Australia, New Zealand, Germany and 4 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT05062291, which also lists 1 linked publication.
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 9 Oct 2026.