ClinicalTrials.gg
Sign In
CompletedNCT04540302WAVEUpdated Jun 10, 2026Results posted

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

An interventional study of Merit WRAPSODY Endovascular Stent Graft and PTA in Venous Stenosis and Venous Occlusion, sponsored by Merit Medical Systems, Inc.. Completed at 43 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Merit Medical Systems, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
357
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Venous Stenosis
  • Venous Occlusion

Browse trials for

Keywords

  • AVF
  • AVG
  • AV fistula
  • AV graft
03

In context

Arteriovenous Fistula

247 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

This study's enrollment of 357 is above the median of 64 across 166 interventional studies indexed under Arteriovenous Fistula.

Browse Arteriovenous Fistula studies →

Lead sponsor

Merit Medical Systems, Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Browse Merit Medical Systems, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject provides written
  • 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 ≥ 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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
357 participants (actual)

Study arms

  • Experimental
    AVF Peripheral study treatment group

    Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft

    Device: Merit WRAPSODY Endovascular Stent Graft

  • Other
    AVF Peripheral control group

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

    Device: 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

Interventions

  • DeviceMerit WRAPSODY Endovascular Stent Graft

    Target lesion treated with stent graft placement

  • DevicePTA

    Target lesion treated with standard percutaneous transluminal angioplasty (PTA)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 24 months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: 12 months

  5. 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.

    Time frame: 24 months

  6. Subjects With Access Circuit Primary Patency (ACPP)

    Time frame: 6 months

  7. Subjects With Access Circuit Primary Patency (ACPP)

    Time frame: 12 months

  8. Subjects With Access Circuit Primary Patency (ACPP)

    Time frame: 24 months

  9. 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.

    Time frame: 6 months

  10. 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.

    Time frame: 12 months

  11. 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.

    Time frame: 24 months

  12. Rates of Procedure-related Adverse Events Involving the Access Circuit

    Rates of procedure-related adverse events involving the access circuit at index procedure

    Time frame: Index procedure

  13. Rates of Device-related Adverse Events Involving the Access Circuit

    Rates of device-related adverse events involving the access circuit at index procedure

    Time frame: Index procedure

  14. Rates of Procedure-related Adverse Events Involving the Access Circuit

    Rates of procedure-related adverse events involving the access circuit at 30 days

    Time frame: 30 days

  15. Rates of Device-related Adverse Events Involving the Access Circuit

    Rates of device-related adverse events involving the access circuit at 30 days

    Time frame: 30 days

  16. Rates of Procedure-related Adverse Events Involving the Access Circuit

    Rates of procedure-related adverse events involving the access circuit at 6 months

    Time frame: 6 months

  17. Rates of Device-related Adverse Events Involving the Access Circuit

    Rates of device-related adverse events involving the access circuit at 6 months

    Time frame: 6 months

  18. Rates of Procedure-related Adverse Events Involving the Access Circuit

    Rates of procedure-related adverse events involving the access circuit at 12 months

    Time frame: 12 Months

  19. Rates of Device-related Adverse Events Involving the Access Circuit

    Rates of device-related adverse events involving the access circuit at 12 months

    Time frame: 12 Months

  20. Rates of Procedure-related Adverse Events Involving the Access Circuit

    Rates of procedure-related adverse events involving the access circuit at 24 months

    Time frame: 24 Months

  21. Rates of Device-related Adverse Events Involving the Access Circuit

    Rates of device-related adverse events involving the access circuit at 24 months

    Time frame: 24 Months

07

Results

Posted Jun 10, 2026

Participant flow

Participant flow — Overall Study
MilestoneAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Started122123112
Completed817054
Not completed415358
Withdrew: Death242521
Withdrew: Withdrawal by subject326
Withdrew: Early termination112428
Withdrew: Lost to follow-up313
Withdrew: Discharge safety follow-up only010

Outcome measures

PrimarySubjects 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)115115104
PrimarySubjects 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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)1037179
SecondarySubjects 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.

Time frame:
12 months
Reported as:
Count of participants · Participants
Subjects With Target Lesion Primary Patency
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Target Lesion Primary Patency764051
SecondarySubjects 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.

Time frame:
24 months
Reported as:
Count of participants · Participants
Subjects With Target Lesion Primary Patency
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Target Lesion Primary Patency422126
SecondarySubjects 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.

Time frame:
6 months
Reported as:
Number · KM estimate (%)
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
KM estimate (%)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Assisted Target Lesion Primary Patency (aTLPP)99.199.197.1
SecondarySubjects 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.

Time frame:
12 months
Reported as:
Number · KM estimate (%)
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
KM estimate (%)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Assisted Target Lesion Primary Patency (aTLPP)99.199.193.4
SecondarySubjects 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.

Time frame:
24 months
Reported as:
Number · KM estimate (%)
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
KM estimate (%)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Assisted Target Lesion Primary Patency (aTLPP)97.999.192.0
SecondarySubjects With Access Circuit Primary Patency (ACPP)
Time frame:
6 months
Reported as:
Count of participants · Participants
Subjects With Access Circuit Primary Patency (ACPP)
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Access Circuit Primary Patency (ACPP)836568
SecondarySubjects With Access Circuit Primary Patency (ACPP)
Time frame:
12 months
Reported as:
Count of participants · Participants
Subjects With Access Circuit Primary Patency (ACPP)
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Access Circuit Primary Patency (ACPP)623331
SecondarySubjects With Access Circuit Primary Patency (ACPP)
Time frame:
24 months
Reported as:
Count of participants · Participants
Subjects With Access Circuit Primary Patency (ACPP)
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Access Circuit Primary Patency (ACPP)271517
SecondarySubjects 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.

Time frame:
6 months
Reported as:
Number · KM estimate (%)
Subjects With Post-Procedure Secondary Patency
KM estimate (%)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Post-Procedure Secondary Patency10010095.1
SecondarySubjects 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.

Time frame:
12 months
Reported as:
Number · KM estimate (%)
Subjects With Post-Procedure Secondary Patency
KM estimate (%)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Post-Procedure Secondary Patency10097.088.4
SecondarySubjects 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.

Time frame:
24 months
Reported as:
Number · KM estimate (%)
Subjects With Post-Procedure Secondary Patency
KM estimate (%)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Subjects With Post-Procedure Secondary Patency97.393.280.2
SecondaryRates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at index procedure

Time frame:
Index procedure
Reported as:
Count of participants · Participants
Rates of Procedure-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Procedure-related Adverse Events Involving the Access Circuit284
SecondaryRates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at index procedure

Time frame:
Index procedure
Reported as:
Count of participants · Participants
Rates of Device-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Device-related Adverse Events Involving the Access Circuit061
SecondaryRates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 30 days

Time frame:
30 days
Reported as:
Count of participants · Participants
Rates of Procedure-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Procedure-related Adverse Events Involving the Access Circuit51811
SecondaryRates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 30 days

Time frame:
30 days
Reported as:
Count of participants · Participants
Rates of Device-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Device-related Adverse Events Involving the Access Circuit196
SecondaryRates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 6 months

Time frame:
6 months
Reported as:
Count of participants · Participants
Rates of Procedure-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Procedure-related Adverse Events Involving the Access Circuit72014
SecondaryRates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 6 months

Time frame:
6 months
Reported as:
Count of participants · Participants
Rates of Device-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Device-related Adverse Events Involving the Access Circuit398
SecondaryRates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 12 months

Time frame:
12 Months
Reported as:
Count of participants · Participants
Rates of Procedure-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Procedure-related Adverse Events Involving the Access Circuit72114
SecondaryRates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 12 months

Time frame:
12 Months
Reported as:
Count of participants · Participants
Rates of Device-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Device-related Adverse Events Involving the Access Circuit398
SecondaryRates of Procedure-related Adverse Events Involving the Access Circuit

Rates of procedure-related adverse events involving the access circuit at 24 months

Time frame:
24 Months
Reported as:
Count of participants · Participants
Rates of Procedure-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Procedure-related Adverse Events Involving the Access Circuit72114
SecondaryRates of Device-related Adverse Events Involving the Access Circuit

Rates of device-related adverse events involving the access circuit at 24 months

Time frame:
24 Months
Reported as:
Count of participants · Participants
Rates of Device-related Adverse Events Involving the Access Circuit
ParticipantsAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Rates of Device-related Adverse Events Involving the Access Circuit398

Adverse events

Collected over 24 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AVF Peripheral Study Treatment Group24/122 (19.7%)75/122 (61.5%)107/122 (87.7%)
AVF Peripheral Control Group25/123 (20.3%)85/123 (69.1%)121/123 (98.4%)
AVG Anastomosis21/112 (18.8%)82/112 (73.2%)104/112 (92.9%)
Most frequent serious events
Showing 10 of 60
Most frequent serious events
EventAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Restenosis of treated segment (target lesion)Vascular disorders12/12222/1237/112
ThrombosisVascular disorders7/1223/12320/112
Cardiac arrestCardiac disorders11/12210/1233/112
Stenosis (non-target)Vascular disorders9/1226/1237/112
Bacteremia or septicemiaInfections and infestations5/1222/1238/112
Infection, localizedInfections and infestations4/1225/1238/112
PainGeneral disorders4/1224/1238/112
Sepsis or systemic infectionInfections and infestations8/1227/1236/112
PneumoniaRespiratory, thoracic and mediastinal disorders6/1228/1236/112
Restenosis (non-target lesion)Vascular disorders6/1226/1237/112
Most frequent other events
Showing 10 of 16
Most frequent other events
EventAVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG Anastomosis
Restenosis of treated segment (target lesion)Vascular disorders39/12272/12322/112
Stenosis (non-target)Vascular disorders40/12232/12339/112
Restenosis (non-target lesion)Vascular disorders32/12231/12333/112
ThrombosisVascular disorders10/1227/12329/112
PainGeneral disorders12/1229/12314/112
Dialysis Access ComplicationsInjury, poisoning and procedural complications10/1223/1239/112
Sepsis or systemic infectionInfections and infestations9/1227/1237/112
PneumoniaRespiratory, thoracic and mediastinal disorders6/1229/1237/112
Bacteremia or septicemiaInfections and infestations5/1222/1238/112
Infection, localizedInfections and infestations5/1227/1238/112

Baseline characteristics

Age, Continuous
Age, Continuous(years)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG AnastomosisTotal
Mean61.6 ± 13.960.1 ± 14.564.1 ± 13.361.8 ± 13.96
Sex: Female, Male
Sex: Female, Male(Participants)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG AnastomosisTotal
Female525461167
Male706951190
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG AnastomosisTotal
Hispanic or Latino413728106
Not Hispanic or Latino818683250
Unknown or Not Reported0011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG AnastomosisTotal
American Indian or Alaska Native2013
Asian36312
Native Hawaiian or Other Pacific Islander1001
Black or African American475169167
White656234161
More than one race44513
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)AVF Peripheral Study Treatment GroupAVF Peripheral Control GroupAVG AnastomosisTotal
Canada1034
United States999885282
Brazil17181752
United Kingdom57719
08

Study locations

43 sites
  • Southwest Kidney institute (SKI) Vascular Center
    Tempe, Arizona 85281, United States
  • Pima Heart and Vascular
    Tucson, Arizona 85718, United States
  • St. Joseph Hospital
    Orange, California 92868, United States
  • Vascular Care Connecticut
    Darien, Connecticut 06820, United States
  • Nephrology Associates
    Newark, Delaware 19713, United States
  • First Coast Cardiovascular Institute
    Jacksonville, Florida 32256, United States
  • Open Access Miami, LLC
    Miami, Florida 33169, United States
  • Leesburg Vascular Access Center & Discovery Medical Research
    Oscala, Florida 34471, United States
  • Coastal Vascular and Interventional
    Pensacola, Florida 32504, United States
  • Chicago Access Center
    Chicago, Illinois 60559, United States
  • Northwestern Medical Center
    Chicago, Illinois 60611, United States
  • Indiana University Hospital and Methodist Hospital
    Indianapolis, Indiana 46202, United States
  • King's Daughters Medical Center
    Ashland, Kentucky 41101, United States
  • Brigham and Women's Faulkner Hospital
    West Roxbury, Massachusetts 02130, United States
  • Michigan Vascular Access Center
    Flint, Michigan 48507, United States
  • Vascular Institute of Atlantic Medical Imaging
    Vineland, New Jersey 80360, United States
  • UNC Health
    Chapel Hill, North Carolina 27599, United States
  • Charlotte Radiology
    Charlotte, North Carolina 28202, United States
  • NC Heart and Vascular Research
    Raleigh, North Carolina 27607, United States
  • North Carolina Nephrology Raleigh Access
    Raleigh, North Carolina 27610, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • University Pittsburg Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • Providence Access Center
    Providence, Rhode Island 02906, United States
  • Prisma Health System Upstate
    Greenville, South Carolina 29605, United States
  • Soltero Cardiovascular Research Center
    Dallas, Texas 75226, United States
  • Renal Disease Research Institute
    Dallas, Texas 75235, United States
  • PPG Health PA, DBA-Tarrant Vascular
    Fort Worth, Texas 76104, United States
  • Global Kidney Associates
    Houston, Texas 77008, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
  • University of Texas Health - Memorial Hermann Katy Hospital
    Katy, Texas 77494, United States
  • CDVA
    Pasadena, Texas 77504, United States
  • Dallas Nephrology Associates
    Plano, Texas 75093, United States
  • Sentara Vascular Specialists
    Virginia Beach, Virginia 23507, United States
  • Instituto Santa Marta De Ensino E Pesquisa
    Brasília, Brazil
  • Real Hospital Português de Beneficência em Pernambuco
    Recife, Brazil
  • Hospital Universitário Pedro Ernesto
    Rio de Janeiro, Brazil
  • Instituto Dante Pazzanese de Cardiologia
    São Paulo, Brazil
  • Toronto General Hospital
    Toronto, Canada
  • Queen Elizabeth Hospital
    Birmingham, B15 2TH, United Kingdom
  • Dorset County Hospital
    Dorchester, United Kingdom
  • Royal London Hospital
    London, E1 1FR, United Kingdom
  • Churchill Hospital
    Oxford, OX3 7LE, United Kingdom
  • Lister Hospital
    Stevenage, SG1 4AB, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Feb 2024, 35 months.

Results were first posted in Jun 2026, 2 years 3 months after primary completion.

Of 84 interventional studies with no phase under Arteriovenous Fistula, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2020
First posted
Sep 7, 2020
StartActual
Mar 9, 2021
Primary completionActual
Feb 22, 2024
CompletionActual
Jul 25, 2025
Results first posted
Jun 10, 2026
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04540302
Lead sponsor
Merit Medical Systems, Inc.
Responsible party
Sponsor
First posted
Sep 7, 2020
Start date
Mar 9, 2021
Primary completion
Feb 22, 2024
Completion
Jul 25, 2025
Results posted
Jun 10, 2026
Last update
Jun 10, 2026

Study contacts

Mahmood K Razavi, MD
principal investigator · St. Joseph's Hospital, Orange, CA
Robert Jones, MD
principal investigator · The Queen Elizabeth Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arteriovenous Fistula →

Other studies from this sponsor

Merit Medical Systems, Inc. →

Start the discussion