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

Active, not recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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

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

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

Merit Medical Systems, Inc.

Investigators

  • 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)

June 23, 2022

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Venous Stenosis

Clinical Trials on Merit WRAPSODY Endovascular Stent Graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe