Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
- Conditions
- Venous StenosisVenous Occlusion
- Registration Number
- NCT05062291
- Lead Sponsor
- Merit Medical Systems, Inc.
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint) 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).
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint) 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.
- Secondary Outcome Measures
Name Time Method Rates of procedure- and device-related adverse events Index procedure, 30 days, and months 6 Rates of procedure- and device-related adverse events
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) 6, 12 and 24 months Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Proportion of subjects with Access Circuit Primary Patency (ACPP) 6, 12 and 24 months Proportion of subjects with Access Circuit Primary Patency (ACPP)
Proportion of subjects with Target Lesion Primary Patency 12 and 24 months Proportion of subjects with Target Lesion Primary Patency
Trial Locations
- Locations (40)
The General University Hospital of Patras
🇬🇷Río, Greece
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
University of Cologne
🇩🇪Cologne, Germany
Hospital Felicio Rocho
🇧🇷Belo Horizonte, Brazil
Hospital Vera Cruz
🇧🇷Campinas, Brazil
Instituto Pro Renal
🇧🇷Curitiba, Brazil
Hospital Evangelico de Londrina
🇧🇷Londrina, Brazil
Parana Medical Research Center
🇧🇷Parnana, Brazil
Rio de Janeiro State University
🇧🇷Rio de Janeiro, Brazil
Hospital Santa Rita de Cassia
🇧🇷Sao Paulo, Brazil
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Monash Health
🇦🇺Clayton, Australia
Austin Hospital
🇦🇺Heidelberg, Australia
Liverpool Hospital
🇦🇺Liverpool, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Afya Hospital
🇧🇷Brasília, Brazil
Hospital Santa Lucia
🇧🇷Brasília, Brazil
Complexo Hospitalar de Niterói
🇧🇷Niterói, Brazil
Hospital Mae de Deus
🇧🇷Porto Alegre, Brazil
Real Hospital Português de Beneficência em Pernambuco
🇧🇷Recife, Brazil
Impar Servicos Hospitalares S/A - Hospital Sao Lucas
🇧🇷Rio De Janeiro, Brazil
Instituto Dor De Pesquisa E Ensino Regional Pernambuco
🇧🇷Rio De Janeiro, Brazil
Hospital Da Bahia
🇧🇷Salvador, Brazil
Centro Internacional de Pesquisa do Hospital Alemão Oswaldo Cruz
🇧🇷São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷São Paulo, Brazil
Protestant Hospital Queen Elisabeth Herzberge
🇩🇪Berlin, Germany
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Maastricht UMC+
🇳🇱Maastricht, Netherlands