The Merit WRAPSODY AV Access Efficacy Study (WAVE)

NCT04540302 | Active Not Recruiting FDA Device

• 1 other identifier: CVO-P3-20-01
• Study Type: interventional
• Target: 357
• Locations: 4 countries
• Sites: 43

Brief Summary

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit

Conditions

Venous Stenosis; Venous Occlusion

Keywords

AVF; AVG; AV fistula; AV graft

Outcome Measures

Primary Outcomes (2)

• 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). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.

  30 days

• 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

Secondary Outcomes (5)

• 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

• Proportion of subjects with Post-Procedure Secondary Patency

  6, 12 and 24 months

• Rates of procedure- and device-related adverse events involving the access circuit

  Index procedure, 30 days, and months 6, 12 and 24.

Study Arms (3)

AVF Peripheral study treatment group

EXPERIMENTAL

Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft

Device: Merit WRAPSODY Endovascular Stent Graft

AVF Peripheral control group

OTHER

Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)

Device: PTA

AVG Anastomosis

EXPERIMENTAL

All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft

Device: Merit WRAPSODY Endovascular Stent Graft

Interventions

Merit WRAPSODY Endovascular Stent Graft DEVICE

Target lesion treated with stent graft placement

AVF Peripheral study treatment group; AVG Anastomosis

PTA DEVICE

Target lesion treated with standard percutaneous transluminal angioplasty (PTA)

AVF Peripheral control group

Eligibility Criteria

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

You may qualify if:

• Subject provides written informed consent
• Subject is male or female, with an age ≥ 18 years at date of enrollment.
• Subject is willing to undergo all follow-up assessments.
• Subject has a life expectancy ≥ 12 months.
• Subject is undergoing chronic hemodialysis.
• Subject has either a mature AVF or AVG in the arm.
• Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
• Target lesion has ≥50% stenosis.
• Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

You may not qualify if:

• Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
• Subject has a stroke diagnosis within 3 months prior to enrollment.
• Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
• Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
• Target lesion is located within a stent / stent graft.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (43)

Southwest Kidney institute (SKI) Vascular Center

Tempe, Arizona, 85281, United States

Location

Pima Heart and Vascular

Tucson, Arizona, 85718, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

Location

Nephrology Associates

Newark, Delaware, 19713, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Open Access Miami, LLC

Miami, Florida, 33169, United States

Location

Leesburg Vascular Access Center & Discovery Medical Research

Oscala, Florida, 34471, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

Chicago Access Center

Chicago, Illinois, 60559, United States

Location

Northwestern Medical Center

Chicago, Illinois, 60611, United States

Location

Indiana University Hospital and Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

King's Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Brigham and Women's Faulkner Hospital

West Roxbury, Massachusetts, 02130, United States

Location

Michigan Vascular Access Center

Flint, Michigan, 48507, United States

Location

Vascular Institute of Atlantic Medical Imaging

Vineland, New Jersey, 80360, United States

Location

UNC Health

Chapel Hill, North Carolina, 27599, United States

Location

Charlotte Radiology

Charlotte, North Carolina, 28202, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

North Carolina Nephrology Raleigh Access

Raleigh, North Carolina, 27610, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Providence Access Center

Providence, Rhode Island, 02906, United States

Location

Prisma Health System Upstate

Greenville, South Carolina, 29605, United States

Location

Soltero Cardiovascular Research Center

Dallas, Texas, 75226, United States

Location

Renal Disease Research Institute

Dallas, Texas, 75235, United States

Location

PPG Health PA, DBA-Tarrant Vascular

Fort Worth, Texas, 76104, United States

Location

Global Kidney Associates

Houston, Texas, 77008, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health - Memorial Hermann Katy Hospital

Katy, Texas, 77494, United States

Location

CDVA

Pasadena, Texas, 77504, United States

Location

Dallas Nephrology Associates

Plano, Texas, 75093, United States

Location

Sentara Vascular Specialists

Virginia Beach, Virginia, 23507, United States

Location

Instituto Santa Marta De Ensino E Pesquisa

Brasília, Brazil

Location

Real Hospital Português de Beneficência em Pernambuco

Recife, Brazil

Location

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Toronto General Hospital

Toronto, Canada

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Dorset County Hospital

Dorchester, United Kingdom

Location

Royal London Hospital

London, E1 1FR, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Lister Hospital

Stevenage, SG1 4AB, United Kingdom

Location

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

• Mahmood K Razavi, MD

  St. Joseph's Hospital, Orange, CA

  PRINCIPAL INVESTIGATOR

• Robert Jones, MD

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study comprises 2 independent cohorts: 1. Up to 244 AVF Peripheral Subjects (1:1 randomization, with approximately 122 in the study treatment and control groups) 2. Up to 113 AVG Anastomosis Subjects (no randomization, comparison to Performance Goals)

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: March 9, 2021
• Primary Completion: February 22, 2024
• Study Completion: January 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (33); GB (5); CA (1); BR (4)