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ACTIVE NOT RECRUITING
NCT05062291

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

Sponsor: Merit Medical Systems, Inc.

View on ClinicalTrials.gov

Summary

The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2022-06-23

Completion Date

2027-10-15

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DEVICE

Merit WRAPSODY Endovascular Stent Graft

Target Lesion Primary Patency (TLPP)

Locations (35)

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