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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540302
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Venous Stenosis Venous Occlusion Device: Merit WRAPSODY Endovascular Stent Graft Device: PTA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study comprises 3 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) and
  3. Up to 120 AVF/AVG Central Subjects (1:1 randomization, with approximately 60 in the study treatment and control groups). Central Subjects who experience rupture during predilatation may be treated with WRAPSODY as a bailout procedure (non-randomized). If this occurs, these subjects will be considered enrolled in the study but will not count towards either the overall planned study enrollment of 477 subjects or the planned enrollment of 120 subjects in cohort 3. Such subjects shall be treated as a separate cohort for analysis.)
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : January 2026

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

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

Experimental: AVF/AVG Central 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

AVF/AVG Central control group
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
Device: PTA
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Proportion of subjects with Target Lesion Primary Patency [ Time Frame: 12 and 24 months ]
  2. Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) [ Time Frame: 6, 12 and 24 months ]
  3. Proportion of subjects with Access Circuit Primary Patency (ACPP) [ Time Frame: 6, 12 and 24 months ]
  4. Proportion of subjects with Post-Procedure Secondary Patency [ Time Frame: 6, 12 and 24 months ]
  5. Rates of procedure- and device-related adverse events involving the access circuit [ Time Frame: Index procedure, 30 days, and months 6, 12 and 24. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540302


Contacts
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Contact: Erin McNiff 617-797-5553 emcniff@merit.com
Contact: Vicky Brunk vicky.brunk@merit.com

Locations
Show Show 55 study locations
Sponsors and Collaborators
Merit Medical Systems, Inc.
Investigators
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Principal Investigator: Mahmood K Razavi, MD St. Joseph's Hospital, Orange, CA
Principal Investigator: James Gilbert, MD Churchill Hospital, Oxford, United Kingdom
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Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT04540302    
Other Study ID Numbers: CVO-P3-20-01
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Merit Medical Systems, Inc.:
AVF
AVG
AV fistula
AV graft
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical