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

Venous Occlusion Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062291
• Other study ID #: CVO-P4-21-01
• Status: Recruiting
• Start date: June 23, 2022
• Est. completion date: September 2026

Study information

• Verified date: November 2023
• Source: Merit Medical Systems, Inc.
• Contact: Christopher Weeks
• Phone: +1-385-766-9138
• Email: christopher.weeks[@]merit.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Venous Occlusion
• Venous Stenosis

Intervention

Device:
• Merit WRAPSODY Endovascular Stent Graft
Target Lesion Primary Patency (TLPP)

Locations

Country	Name	City	State
Australia	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
Brazil	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
Germany	Protestant Hospital Queen Elisabeth Herzberge	Berlin
Germany	University of Cologne	Cologne
Greece	The General University Hospital of Patras	Río
Israel	Shaare Zedek Medical Center	Jerusalem
Netherlands	Maastricht UMC+	Maastricht
New Zealand	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
Portugal	CHUC - Centro Hospitalar e Universitário De Coimbra	Coimbra
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Proportion of subjects with Target Lesion Primary Patency	Proportion of subjects with Target Lesion Primary Patency	12 and 24 months
Secondary	Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)	Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)	6, 12 and 24 months
Secondary	Proportion of subjects with Access Circuit Primary Patency (ACPP)	Proportion of subjects with Access Circuit Primary Patency (ACPP)	6, 12 and 24 months
Secondary	Rates of procedure- and device-related adverse events	Rates of procedure- and device-related adverse events	Index procedure, 30 days, and months 6