Clinical trial NCT05062291: Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Stenosis
Venous Occlusion
Keywords: Arteriovenous Fistula (AVF)
Arteriovenous Graft (AVG)
AV fistula
AV graft
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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.

Primary outcomes:
measure: Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
timeFrame: 6 months
measure: Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of subjects with Target Lesion Primary Patency
timeFrame: 12 and 24 months
measure: Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
timeFrame: 6, 12 and 24 months
measure: Proportion of subjects with Access Circuit Primary Patency (ACPP)
timeFrame: 6, 12 and 24 months
measure: Rates of procedure- and device-related adverse events
timeFrame: Index procedure, 30 days, and months 6
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Health
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
city: Brasília
country: Brazil
facility: Afya Hospital
city: Brasília
country: Brazil
facility: Hospital Santa Lucia
city: Campinas
country: Brazil
facility: Hospital Vera Cruz
city: Curitiba
country: Brazil
facility: Instituto Pro Renal
city: Londrina
country: Brazil
facility: Hospital Evangelico de Londrina
city: Niterói
country: Brazil
facility: Complexo Hospitalar de Niterói
city: Parnana
country: Brazil
facility: Parana Medical Research Center
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
city: Recife
country: Brazil
facility: Real Hospital Português de Beneficência em Pernambuco
city: Rio De Janeiro
country: Brazil
facility: Impar Servicos Hospitalares S/A - Hospital Sao Lucas
city: Rio De Janeiro
country: Brazil
facility: Instituto Dor De Pesquisa E Ensino Regional Pernambuco
city: Rio de Janeiro
country: Brazil
facility: Rio de Janeiro State University
city: Salvador
country: Brazil
facility: Hospital Da Bahia
city: Sao Paulo
country: Brazil
facility: Hospital Santa Rita de Cassia
city: São Paulo
country: Brazil
facility: Centro Internacional de Pesquisa do Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Berlin
country: Germany
facility: Protestant Hospital Queen Elisabeth Herzberge
city: Cologne
country: Germany
facility: University of Cologne
city: Río
country: Greece
facility: The General University Hospital of Patras
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Auckland
country: New Zealand
facility: Te Toka Tumai Auckland
city: Auckland
country: New Zealand
facility: Te Whatu Ora Health NZ Waitemata
city: Christchurch
country: New Zealand
facility: Te Whatu Ora Health NZ Waitaha Canterbury
city: Hamilton
country: New Zealand
facility: Te Whatu Ora Health New Zealand Waitemata
city: Coimbra
country: Portugal
facility: CHUC - Centro Hospitalar e Universitário De Coimbra
city: Belfast
country: United Kingdom
facility: Belfast City Hospital, Belfast Health and Social Care Trust
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital, University Hospital Birmingham
city: London
country: United Kingdom
facility: King's College Hospital, NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal London Hospital, Barts Health NHS Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
Study officials:
affiliation: University of Toronto
name: Dheeraj Rajan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Patras
name: Panagiotis Kitrou
role: PRINCIPAL_INVESTIGATOR
References: