Skip to main content
OpenTrials
Completed

NCT Number: NCT04540302

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Stenosis Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations Venous Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Santa Marta De Ensino E Pesquisa, Brasília, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Merit WRAPSODY Endovascular Stent Graft

Device

Target lesion treated with stent graft placement

PTA

Device

Target lesion treated with standard percutaneous transluminal angioplasty (PTA)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Subjects With Target Lesion Primary Patency

    Time frame: 12 months

    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.

  2. Subjects With Target Lesion Primary Patency

    Time frame: 24 months

    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.

  3. Subjects With Assisted Target Lesion Primary Patency (aTLPP)

    Time frame: 6 months

    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.

  4. Subjects With Assisted Target Lesion Primary Patency (aTLPP)

    Time frame: 12 months

    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.

  5. Subjects With Assisted Target Lesion Primary Patency (aTLPP)

    Time frame: 24 months

    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.

  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

    Time frame: 6 months

    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.

  10. Subjects With Post-Procedure Secondary Patency

    Time frame: 12 months

    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.

  11. Subjects With Post-Procedure Secondary Patency

    Time frame: 24 months

    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.

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

    Time frame: Index procedure

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

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

    Time frame: Index procedure

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

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

    Time frame: 30 days

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

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

    Time frame: 30 days

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 Months

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

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

    Time frame: 12 Months

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

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

    Time frame: 24 Months

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

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

    Time frame: 24 Months

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

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Registry information

Official study 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

Acronym: WAVE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 7, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.