Venous Stenosis, Venous Occlusion
Conditions
Keywords
AVF, AVG, AV fistula, AV graft
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
Interventions
Target lesion treated with stent graft placement
DEVICEPTA
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
Sponsors
Merit Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study comprises 2 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of subjects with Access Circuit Primary Patency (ACPP) | 6, 12 and 24 months |
| Proportion of subjects with Target Lesion Primary Patency | 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. |
| Proportion of subjects with Post-Procedure Secondary Patency | 6, 12 and 24 months |
| Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) | 6, 12 and 24 months |
Countries
Brazil, Canada, United Kingdom, United States
Outcome results
None listed