Venous StenosisWAVENCT04540302
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
A study testing Merit WRAPSODY Endovascular Stent Graft and PTA in people with Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc. at 43 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stenosis, Venous Occlusion
- What is being tested?
- Merit WRAPSODY Endovascular Stent Graft and PTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 43 sitesin 4 countries
- Study dates
- 9 Mar 2021to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
43 sites in 4 countries.
43 sites in 4 countries
United States33 sites
King's Daughters Medical Center
Ashland, Kentucky, 41101
UNC Health
Chapel Hill, North Carolina, 27599
Charlotte Radiology
Charlotte, North Carolina, 28202
Chicago Access Center
Chicago, Illinois, 60559
Northwestern Medical Center
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Soltero Cardiovascular Research Center
Dallas, Texas, 75226
Renal Disease Research Institute
Dallas, Texas, 75235
Vascular Care Connecticut
Darien, Connecticut, 06820
Michigan Vascular Access Center
Flint, Michigan, 48507
PPG Health PA, DBA-Tarrant Vascular
Fort Worth, Texas, 76104
Prisma Health System Upstate
Greenville, South Carolina, 29605
Global Kidney Associates
Houston, Texas, 77008
Houston Methodist Hospital
Houston, Texas, 77030
Indiana University Hospital and Methodist Hospital
Indianapolis, Indiana, 46202
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
University of Texas Health - Memorial Hermann Katy Hospital
Katy, Texas, 77494
Open Access Miami, LLC
Miami, Florida, 33169
Nephrology Associates
Newark, Delaware, 19713
St. Joseph Hospital
Orange, California, 92868
Leesburg Vascular Access Center & Discovery Medical Research
Oscala, Florida, 34471
CDVA
Pasadena, Texas, 77504
Coastal Vascular and Interventional
Pensacola, Florida, 32504
University Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
Dallas Nephrology Associates
Plano, Texas, 75093
Providence Access Center
Providence, Rhode Island, 02906
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
North Carolina Nephrology Raleigh Access
Raleigh, North Carolina, 27610
Southwest Kidney institute (SKI) Vascular Center
Tempe, Arizona, 85281
Pima Heart and Vascular
Tucson, Arizona, 85718
Vascular Institute of Atlantic Medical Imaging
Vineland, New Jersey, 80360
Sentara Vascular Specialists
Virginia Beach, Virginia, 23507
Brigham and Women's Faulkner Hospital
West Roxbury, Massachusetts, 02130
United Kingdom5 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Dorset County Hospital
Dorchester
Royal London Hospital
London, E1 1FR
Churchill Hospital
Oxford, OX3 7LE
Lister Hospital
Stevenage, SG1 4AB
Brazil4 sites
Instituto Santa Marta De Ensino E Pesquisa
Brasília
Real Hospital Português de Beneficência em Pernambuco
Recife
Hospital Universitário Pedro Ernesto
Rio de Janeiro
Instituto Dante Pazzanese de Cardiologia
São Paulo
About this study
Official title: 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
- Conditions
- Venous Stenosis, Venous Occlusion
- Being tested
- Merit WRAPSODY Endovascular Stent Graft, PTA
- Keywords
- AVF, AVG, AV fistula, AV graft
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merit WRAPSODY Endovascular Stent GraftDevice
Target lesion treated with stent graft placement
PTADevice
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
| Study group | Role | What they receive |
|---|---|---|
| AVF Peripheral study treatment group | Experimental | Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft Receives: Device: Merit WRAPSODY Endovascular Stent Graft |
| AVF Peripheral control group | Other | Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) Receives: Device: PTA |
| AVG Anastomosis | Experimental | All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft Receives: Device: Merit WRAPSODY Endovascular Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Subjects With Access Circuit Primary Patency (ACPP)
Measured: 6 months
Subjects With Access Circuit Primary Patency (ACPP)
Measured: 12 months
Subjects With Access Circuit Primary Patency (ACPP)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start9 Mar 2021
- Primary completion22 Feb 2024
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmood K Razavi, MD, Principal investigator, St. Joseph's Hospital, Orange, CARobert Jones, MD, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540302
- Sponsor's protocol ID
- CVO-P3-20-01
- Acronym
- WAVE
- Status last verified
- Apr 2026
- First submitted
- 1 Sep 2020
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04540302
- Acronym / sponsor ID
- WAVE / CVO-P3-20-01
- Conditions
- Venous Stenosis, Venous Occlusion
- Keywords
- AVF, AVG, AV fistula, AV graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| AVF Peripheral study treatment group | Experimental | Device: Merit WRAPSODY Endovascular Stent GraftSubjects randomised to treatment with the WRAPSODY Endovascular Stent Graft |
| AVF Peripheral control group | Other | Device: PTASubjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) |
| AVG Anastomosis | Experimental | Device: Merit WRAPSODY Endovascular Stent GraftAll subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Merit WRAPSODY Endovascular Stent GraftTarget lesion treated with stent graft placement | Device | AVF Peripheral study treatment group, AVG Anastomosis |
| PTATarget lesion treated with standard percutaneous transluminal angioplasty (PTA) | Device | AVF Peripheral control group |
Primary outcome
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)
Time frame: 30 days
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.
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
Time frame: 6 months
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.
21 secondary outcomes
Subjects With Target Lesion Primary Patency
Time frame: 12 months
Subjects With Target Lesion Primary Patency
Time frame: 24 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 6 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 12 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 24 months
Subjects With Access Circuit Primary Patency (ACPP)
Time frame: 6 months
Subjects With Access Circuit Primary Patency (ACPP)
Time frame: 12 months
Subjects With Access Circuit Primary Patency (ACPP)
Time frame: 24 months
Subjects With Post-Procedure Secondary Patency
Time frame: 6 months
Subjects With Post-Procedure Secondary Patency
Time frame: 12 months
Subjects With Post-Procedure Secondary Patency
Time frame: 24 months
Rates of Procedure-related Adverse Events Involving the Access Circuit
Time frame: Index procedure
Rates of Device-related Adverse Events Involving the Access Circuit
Time frame: Index procedure
Rates of Procedure-related Adverse Events Involving the Access Circuit
Time frame: 30 days
Rates of Device-related Adverse Events Involving the Access Circuit
Time frame: 30 days
Rates of Procedure-related Adverse Events Involving the Access Circuit
Time frame: 6 months
Rates of Device-related Adverse Events Involving the Access Circuit
Time frame: 6 months
Rates of Procedure-related Adverse Events Involving the Access Circuit
Time frame: 12 Months
Rates of Device-related Adverse Events Involving the Access Circuit
Time frame: 12 Months
Rates of Procedure-related Adverse Events Involving the Access Circuit
Time frame: 24 Months
Rates of Device-related Adverse Events Involving the Access Circuit
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmood K Razavi, MD principal investigator
St. Joseph's Hospital, Orange, CA
Robert Jones, MD principal investigator
The Queen Elizabeth Hospital
43 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Merit WRAPSODY Endovascular Stent Graft and PTA in people with Venous Stenosis and Venous Occlusion, run by Merit Medical Systems, Inc. at 43 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, United Kingdom, Brazil, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.