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

April 9, 2025 updated by: Merit Medical Systems, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
357

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
Time Frame: 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). 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:)
Time Frame: 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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects with Target Lesion Primary Patency
Time Frame: 12 and 24 months
12 and 24 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Proportion of subjects with Post-Procedure Secondary Patency
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Rates of procedure- and device-related adverse events involving the access circuit
Time Frame: Index procedure, 30 days, and months 6, 12 and 24.
Index procedure, 30 days, and months 6, 12 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merit Medical Systems, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Jones, MD, The Queen Elizabeth Hospital
  • Principal Investigator: Mahmood K Razavi, MD, St. Joseph's Hospital, Orange, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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