Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

December 9, 2025 updated by: Merit Medical Systems, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
      • Clayton, Australia
        • Monash Health
      • Liverpool, Australia
        • Liverpool Hospital
      • Murdoch, Australia
        • Fiona Stanley Hospital
      • Nedlands, Australia
        • Sir Charles Gairdner Hospital
      • Woolloongabba, Australia
        • Princess Alexandra Hospital
  • Brazil
      • Belo Horizonte, Brazil
        • Hospital Felicio Rocho
      • Brasília, Brazil
        • Afya Hospital
      • Brasília, Brazil
        • Hospital Santa Lucía
      • Campinas, Brazil
        • Hospital Vera Cruz
      • Curitiba, Brazil
        • Instituto Pro Renal
      • Niterói, Brazil
        • Complexo Hospitalar de Niteroi
      • Paranã, Brazil
        • Parana Medical Research Center
      • Recife, Brazil
        • Real Hospital Português de Beneficência em Pernambuco
      • Rio de Janeiro, Brazil
        • Impar Servicos Hospitalares S/A - Hospital Sao Lucas
      • Rio de Janeiro, Brazil
        • Rio de Janeiro State University
      • Salvador, Brazil
        • Hospital Da Bahia
      • São Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil
        • Centro Internacional de Pesquisa do Hospital Alemão Oswaldo Cruz
      • São Paulo, Brazil
        • Hospital Santa Rita de Cassia
  • Germany
      • Berlin, Germany
        • Protestant Hospital Queen Elisabeth Herzberge
      • Cologne, Germany
        • University of Cologne
  • Greece
      • Rio, Greece
        • The General University Hospital of Patras
  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht UMC+
  • New Zealand
      • Auckland, New Zealand
        • Te Toka Tumai Auckland
      • Auckland, New Zealand
        • Te Whatu Ora Health NZ Waitemata
      • Christchurch, New Zealand
        • Te Whatu Ora Health NZ Waitaha Canterbury
      • Hamilton, New Zealand
        • Te Whatu Ora Health New Zealand Waitemata
  • Portugal
      • Coimbra, Portugal
        • CHUC - Centro Hospitalar e Universitário de Coimbra
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast City Hospital, Belfast Health and Social Care Trust
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital, University Hospital Birmingham
      • London, United Kingdom
        • Royal London Hospital, Barts Health NHS Trust
      • London, United Kingdom
        • King's College Hospital, NHS Foundation Trust
      • Oxford, United Kingdom
        • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
      • Reading, United Kingdom
        • Royal Berkshire NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

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 24 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 of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System 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 titanium alloy.
  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 Percutaneous Transluminal Angioplasty (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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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).
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with Target Lesion Primary Patency
Time Frame: 12 and 24 months
Proportion of subjects with Target Lesion Primary Patency
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 Assisted Target Lesion Primary Patency (aTLPP)
6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time Frame: 6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
6, 12 and 24 months
Rates of procedure- and device-related adverse events
Time Frame: Index procedure, 30 days, and months 6
Rates of procedure- and device-related adverse events
Index procedure, 30 days, and months 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merit Medical Systems, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dheeraj Rajan, MD, University of Toronto
  • Principal Investigator: Panagiotis Kitrou, University Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVO-P4-21-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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