The Merit WRAPSODY AV Access Efficacy Study (WAVE)

Not Applicable

Active, not recruiting

• Conditions: Venous Occlusion; Venous Stenosis

• Registration Number: NCT04540302
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-07
• Study Start: 2021-03-09
• Primary Completion: 2024-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 357

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)	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.
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)	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

Name	Time	Method
Rates of procedure- and device-related adverse events involving the access circuit	Index procedure, 30 days, and months 6, 12 and 24.
Proportion of subjects with Target Lesion Primary Patency	12 and 24 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)	6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)	6, 12 and 24 months
Proportion of subjects with Post-Procedure Secondary Patency	6, 12 and 24 months

Trial Locations

Locations (43)

Southwest Kidney institute (SKI) Vascular Center; 🇺🇸 Tempe, Arizona, United States

Pima Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

St. Joseph Hospital; 🇺🇸 Orange, California, United States

Vascular Care Connecticut; 🇺🇸 Darien, Connecticut, United States

Nephrology Associates; 🇺🇸 Newark, Delaware, United States

First Coast Cardiovascular Institute; 🇺🇸 Jacksonville, Florida, United States

Open Access Miami, LLC; 🇺🇸 Miami, Florida, United States

Leesburg Vascular Access Center & Discovery Medical Research; 🇺🇸 Oscala, Florida, United States

Coastal Vascular and Interventional; 🇺🇸 Pensacola, Florida, United States

Chicago Access Center; 🇺🇸 Chicago, Illinois, United States

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