Back to resultsThe Merit WRAPSODY Central Feasibility Study (WAVE Central)
Primary Purpose
Venous Stenosis, Venous Occlusion
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Merit WRAPSODY Endovascular Stent Graft
Sponsored by
About this trial
This is an interventional treatment trial for Venous Stenosis
Eligibility 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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WRAPSODY Stent Graft
Arm Description
All subjects will receive treatment via WRAPSODY Stent Graft Placement.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Proportion of subjects with Target Lesion Primary Patency
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Proportion of subjects with Post-Procedure Secondary Patency
Rates of procedure- and device-related adverse events involving the access circuit
Full Information
NCT ID
NCT04541576
First Posted
September 1, 2020
Last Updated
April 16, 2021
Sponsor
Merit Medical Systems, Inc.
Collaborators
ClinLogix. LLC
1. Study Identification
Unique Protocol Identification Number
NCT04541576
Brief Title
The Merit WRAPSODY Central Feasibility Study
Acronym
WAVE Central
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
FDA Approval
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merit Medical Systems, Inc.
Collaborators
ClinLogix. LLC
4. Oversight
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
5. Study Description
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 in the thoracic central veins
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stenosis, Venous Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WRAPSODY Stent Graft
Arm Type
Experimental
Arm Description
All subjects will receive treatment via WRAPSODY Stent Graft Placement.
Intervention Type
Device
Intervention Name(s)
Merit WRAPSODY Endovascular Stent Graft
Intervention Description
Target lesion treated with stent graft placement
Primary Outcome Measure Information:
Title
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint
Description
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.
Time Frame
30 days
Title
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of subjects with Target Lesion Primary Patency
Time Frame
12 and 24 months
Title
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time Frame
6, 12 and 24 months
Title
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time Frame
6, 12 and 24 months
Title
Proportion of subjects with Post-Procedure Secondary Patency
Time Frame
6, 12 and 24 months
Title
Rates of procedure- and device-related adverse events involving the access circuit
Time Frame
Index procedure, 30 days, and months 6, 12 and 24.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Merit WRAPSODY Central Feasibility Study
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