The Merit WRAPSODY Central Feasibility Study (WAVE Central)

Prospective, Non-Randomized, Controlled, Multicenter Feasibility Study of the Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Central Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients

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 in the thoracic central veins

Study Overview

• Status: Withdrawn
• Conditions: Venous Stenosis; Venous Occlusion
• Intervention / Treatment: Device: Merit WRAPSODY Endovascular Stent Graft

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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 is unable or is unwilling to comply with the procedural requirements of the study protocol.
• Subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WRAPSODY Stent Graft; All subjects will receive treatment via WRAPSODY Stent Graft Placement.	Device: Merit WRAPSODY Endovascular Stent Graft; Target lesion treated with stent graft placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)	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.	6 months
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint	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 intervention, hospitalization, or death.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Rates of procedure- and device-related adverse events involving the access circuit	Index procedure, 30 days, and months 6, 12 and 24.

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Collaborators: ClinLogix. LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: CVO-P3-20-01-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes