The Merit WRAPSODY AV Access Efficacy Study (WAVE) (WAVE)

Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study

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

Study Overview

• Status: Completed
• Conditions: Venous Stenosis; Venous Occlusion
• Intervention / Treatment: Device: Merit WRAPSODY Endovascular Stent Graft; Device: PTA

• Study Type: Interventional
• Enrollment (Actual): 357
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Brasília, Brazil
    • Instituto Santa Marta De Ensino E Pesquisa
  • Recife, Brazil
    • Real Hospital Português de Beneficência em Pernambuco
  • Rio de Janeiro, Brazil
    • Hospital Universitário Pedro Ernesto
  • São Paulo, Brazil
    • Instituto Dante Pazzanese de Cardiologia
• Canada
  • Toronto, Canada
    • Toronto General Hospital
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Dorchester, United Kingdom
    • Dorset County Hospital
  • London, United Kingdom, E1 1FR
    • Royal London Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital
  • Stevenage, United Kingdom, SG1 4AB
    • Lister Hospital
• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Southwest Kidney institute (SKI) Vascular Center
    • Tucson, Arizona, United States, 85718
      • Pima Heart and Vascular
  • California
    • Orange, California, United States, 92868
      • St. Joseph Hospital
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Vascular Care Connecticut
  • Delaware
    • Newark, Delaware, United States, 19713
      • Nephrology Associates
  • Florida
    • Jacksonville, Florida, United States, 32256
      • First Coast Cardiovascular Institute
    • Miami, Florida, United States, 33169
      • Open Access Miami, LLC
    • Oscala, Florida, United States, 34471
      • Leesburg Vascular Access Center & Discovery Medical Research
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular and Interventional
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Center
    • Chicago, Illinois, United States, 60559
      • Chicago Access Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital and Methodist Hospital
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • King's Daughters Medical Center
  • Massachusetts
    • West Roxbury, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital
  • Michigan
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Access Center
  • New Jersey
    • Vineland, New Jersey, United States, 80360
      • Vascular Institute of Atlantic Medical Imaging
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Health
    • Charlotte, North Carolina, United States, 28202
      • Charlotte Radiology
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research
    • Raleigh, North Carolina, United States, 27610
      • North Carolina Nephrology Raleigh Access
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University Pittsburg Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Providence Access Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health System Upstate
  • Texas
    • Dallas, Texas, United States, 75235
      • Renal Disease Research Institute
    • Dallas, Texas, United States, 75226
      • Soltero Cardiovascular Research Center
    • Fort Worth, Texas, United States, 76104
      • PPG Health PA, DBA-Tarrant Vascular
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77008
      • Global Kidney Associates
    • Katy, Texas, United States, 77494
      • University of Texas Health - Memorial Hermann Katy Hospital
    • Pasadena, Texas, United States, 77504
      • CDVA
    • Plano, Texas, United States, 75093
      • Dallas Nephrology Associates
  • Virginia
    • Virginia Beach, Virginia, United States, 23507
      • Sentara Vascular Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVF Peripheral study treatment group; Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft	Device: Merit WRAPSODY Endovascular Stent Graft; Target lesion treated with stent graft placement
Other: AVF Peripheral control group; Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)	Device: PTA; Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
Experimental: AVG Anastomosis; All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft	Device: Merit WRAPSODY Endovascular Stent Graft; Target lesion treated with stent graft placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)	Percentage 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
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)	Percentage 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With Target Lesion Primary Patency	Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 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.	12 months
Subjects With Target Lesion Primary Patency	Percentage of subjects with Target Lesion Primary Patency (TLPP) at 24 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.	24 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)	Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 6 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.	6 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)	Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 12 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.	12 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)	Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 24 months. aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.	24 months
Subjects With Access Circuit Primary Patency (ACPP)		6 months
Subjects With Access Circuit Primary Patency (ACPP)		12 months
Subjects With Access Circuit Primary Patency (ACPP)		24 months
Subjects With Post-Procedure Secondary Patency	Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 6 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.	6 months
Subjects With Post-Procedure Secondary Patency	Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 12 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.	12 months
Subjects With Post-Procedure Secondary Patency	Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 24 months. Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.	24 months
Rates of Procedure-related Adverse Events Involving the Access Circuit	Rates of procedure-related adverse events involving the access circuit at index procedure	Index procedure
Rates of Device-related Adverse Events Involving the Access Circuit	Rates of device-related adverse events involving the access circuit at index procedure	Index procedure
Rates of Procedure-related Adverse Events Involving the Access Circuit	Rates of procedure-related adverse events involving the access circuit at 30 days	30 days
Rates of Device-related Adverse Events Involving the Access Circuit	Rates of device-related adverse events involving the access circuit at 30 days	30 days
Rates of Procedure-related Adverse Events Involving the Access Circuit	Rates of procedure-related adverse events involving the access circuit at 6 months	6 months
Rates of Device-related Adverse Events Involving the Access Circuit	Rates of device-related adverse events involving the access circuit at 6 months	6 months
Rates of Procedure-related Adverse Events Involving the Access Circuit	Rates of procedure-related adverse events involving the access circuit at 12 months	12 Months
Rates of Device-related Adverse Events Involving the Access Circuit	Rates of device-related adverse events involving the access circuit at 12 months	12 Months
Rates of Procedure-related Adverse Events Involving the Access Circuit	Rates of procedure-related adverse events involving the access circuit at 24 months	24 Months
Rates of Device-related Adverse Events Involving the Access Circuit	Rates of device-related adverse events involving the access circuit at 24 months	24 Months

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Investigators: Principal Investigator: Robert Jones, MD, The Queen Elizabeth Hospital; Principal Investigator: Mahmood K Razavi, MD, St. Joseph's Hospital, Orange, CA

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: AVF; AV fistula; AV graft; AVG
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Arteriovenous Fistula
• Other Study ID Numbers: CVO-P3-20-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No