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

NCT ID: NCT05062291

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2027-10-15

Brief Summary

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)

Conditions

Venous Stenosis; Venous Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Merit WRAPSODY Endovascular Stent Graft

Target Lesion Primary Patency (TLPP)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dheeraj Rajan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Panagiotis Kitrou

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Locations

Monash Health

Clayton, , Australia

Liverpool Hospital

Liverpool, , Australia

Fiona Stanley Hospital

Murdoch, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

Hospital Felicio Rocho

Belo Horizonte, , Brazil

Afya Hospital

Brasília, , Brazil

Hospital Santa Lucia

Brasília, , Brazil

Hospital Vera Cruz

Campinas, , Brazil

Instituto Pro Renal

Curitiba, , Brazil

Complexo Hospitalar de Niterói

Niterói, , Brazil

Parana Medical Research Center

Paranã, , Brazil

Real Hospital Português de Beneficência em Pernambuco

Recife, , Brazil

Impar Servicos Hospitalares S/A - Hospital Sao Lucas

Rio de Janeiro, , Brazil

Rio de Janeiro State University

Rio de Janeiro, , Brazil

Hospital Da Bahia

Salvador, , Brazil

Centro Internacional de Pesquisa do Hospital Alemão Oswaldo Cruz

São Paulo, , Brazil

Hospital Santa Rita de Cassia

São Paulo, , Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Protestant Hospital Queen Elisabeth Herzberge

Berlin, , Germany

University of Cologne

Cologne, , Germany

The General University Hospital of Patras

Rio, , Greece

Shaare Zedek Medical Center

Jerusalem, , Israel

Maastricht UMC+

Maastricht, , Netherlands

Te Toka Tumai Auckland

Auckland, , New Zealand

Te Whatu Ora Health NZ Waitemata

Auckland, , New Zealand

Te Whatu Ora Health NZ Waitaha Canterbury

Christchurch, , New Zealand

Te Whatu Ora Health New Zealand Waitemata

Hamilton, , New Zealand

CHUC - Centro Hospitalar e Universitário De Coimbra

Coimbra, , Portugal

Belfast City Hospital, Belfast Health and Social Care Trust

Belfast, , United Kingdom

Queen Elizabeth Hospital, University Hospital Birmingham

Birmingham, , United Kingdom

King's College Hospital, NHS Foundation Trust

London, , United Kingdom

Royal London Hospital, Barts Health NHS Trust

London, , United Kingdom

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Royal Berkshire NHS Foundation Trust

Reading, , United Kingdom

Countries

Australia; Brazil; Germany; Greece; Israel; Netherlands; New Zealand; Portugal; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37592020 (View on PubMed)

Other Identifiers

CVO-P4-21-01

Identifier Type: -

Identifier Source: org_study_id