The Merit WRAPSODY AV Access Efficacy Study (WAVE)

Study Overview
=================
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

Official Title
-----------------
Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study

Conditions
-----------------
Venous Stenosis, Venous Occlusion

Intervention / Treatment
-----------------
* Device: Merit WRAPSODY Endovascular Stent Graft
* Device: PTA


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study comprises 2 independent cohorts: Up to 244 AVF Peripheral Subjects (1:1 randomization, with approximately 122 in the study treatment and control groups) Up to 113 AVG Anastomosis Subjects (no randomization, comparison to Performance Goals)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVF Peripheral study treatment group<br>Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft | Device: Merit WRAPSODY Endovascular Stent Graft<br>* Target lesion treated with stent graft placement<br>|
| Other: AVF Peripheral control group<br>Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) | Device: PTA<br>* Target lesion treated with standard percutaneous transluminal angioplasty (PTA)<br>|
| Experimental: AVG Anastomosis<br>All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft | Device: Merit WRAPSODY Endovascular Stent Graft<br>* Target lesion treated with stent graft placement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 30 days | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AVF, AVG, AV fistula, AV graft