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

NCT05062291 | Active Not Recruiting

• 1 other identifier: CVO-P4-21-01
• Study Type: observational
• Target: 500
• Locations: 9 countries
• Sites: 35

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.

Conditions

Venous Stenosis; Venous Occlusion

Keywords

Arteriovenous Fistula (AVF); Arteriovenous Graft (AVG); AV fistula; AV graft

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  30 days

Secondary Outcomes (4)

• Proportion of subjects with Target Lesion Primary Patency

  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)

  6, 12 and 24 months

• Rates of procedure- and device-related adverse events

  Index procedure, 30 days, and months 6

Interventions

Merit WRAPSODY Endovascular Stent Graft DEVICE

Target Lesion Primary Patency (TLPP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (35)

Monash Health

Clayton, Australia

Location

Liverpool Hospital

Liverpool, Australia

Location

Fiona Stanley Hospital

Murdoch, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Australia

Location

Hospital Felicio Rocho

Belo Horizonte, Brazil

Location

Afya Hospital

Brasília, Brazil

Location

Hospital Santa Lucia

Brasília, Brazil

Location

Hospital Vera Cruz

Campinas, Brazil

Location

Instituto Pro Renal

Curitiba, Brazil

Location

Complexo Hospitalar de Niterói

Niterói, Brazil

Location

Parana Medical Research Center

Paranã, Brazil

Location

Real Hospital Português de Beneficência em Pernambuco

Recife, Brazil

Location

Impar Servicos Hospitalares S/A - Hospital Sao Lucas

Rio de Janeiro, Brazil

Location

Rio de Janeiro State University

Rio de Janeiro, Brazil

Location

Hospital Da Bahia

Salvador, Brazil

Location

Centro Internacional de Pesquisa do Hospital Alemão Oswaldo Cruz

São Paulo, Brazil

Location

Hospital Santa Rita de Cassia

São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Protestant Hospital Queen Elisabeth Herzberge

Berlin, Germany

Location

University of Cologne

Cologne, Germany

Location

The General University Hospital of Patras

Rio, Greece

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Te Toka Tumai Auckland

Auckland, New Zealand

Location

Te Whatu Ora Health NZ Waitemata

Auckland, New Zealand

Location

Te Whatu Ora Health NZ Waitaha Canterbury

Christchurch, New Zealand

Location

Te Whatu Ora Health New Zealand Waitemata

Hamilton, New Zealand

Location

CHUC - Centro Hospitalar e Universitário De Coimbra

Coimbra, Portugal

Location

Belfast City Hospital, Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

Queen Elizabeth Hospital, University Hospital Birmingham

Birmingham, United Kingdom

Location

King's College Hospital, NHS Foundation Trust

London, United Kingdom

Location

Royal London Hospital, Barts Health NHS Trust

London, United Kingdom

Location

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37592020 DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dheeraj Rajan, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Panagiotis Kitrou

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: June 23, 2022
• Primary Completion: April 15, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); DE (2); BR (14); GR (1); PT (1); GB (6); NZ (4); AU (5); NL (1)