The Merit WRAPSODY AV Access Efficacy Study (WAVE)

Merit Medical Systems

Status: Active, not recruiting

Conditions: Venous Occlusion; Venous Stenosis

Treatments: Device: Merit WRAPSODY Endovascular Stent Graft; Device: PTA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04540302

CVO-P3-20-01

Details and patient eligibility

About

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

Enrollment: 357 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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357 participants in 3 patient groups

AVF Peripheral study treatment group

Experimental group

Description:

Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft

Treatment:

Device: Merit WRAPSODY Endovascular Stent Graft

AVF Peripheral control group

Other group

Description:

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

Treatment:

Device: PTA

AVG Anastomosis

Experimental group

Description:

All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft

Treatment:

Device: Merit WRAPSODY Endovascular Stent Graft