The Merit WRAPSODY™ Endovascular Stent Graft

Study Overview
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Brief Summary
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This is a phase 1 study, designed to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of venous outflow circuit obstructions in the veins of the arm or thoracic central veins of subjects who receive chronic dialysis treatment for end stage renal disease.

Detailed Description
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The study will consist of a screening period in which subject eligibility will be determined. Approximately 50 subjects meeting the study entry criteria will be enrolled. Placement of the WRAPSODY stent graft will follow the procedure. Post study procedure subjects will have planned follow-up visits at 30 days, 3, 6 and 12months, and additional visits as referred by the subject's dialysis facility. The primary study safety endpoint will be the proportion of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death. Subjects will continue to be followed up to 12 months for supplementary information.

Official Title
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Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Venous Outflow Circuit Obstruction In Hemodialysis Patients

Conditions
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Venous Stenosis, Venous Occlusion

Intervention / Treatment
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* Device: WRAPSODY Stent Graft Placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed informed consent Subject is ≥ 21 years of age Subject is undergoing chronic hemodialysis or other forms of renal replacement therapy including transplantation and has one of the following being used: a. AV graft placed in the arm ≥30 days prior OR b. Mature fistula in the arm with at least one successful dialysis session completed Angiographic evidence of stenosis The target lesion has ≥ 50% stenosis Subject has clinical or hemodynamic evidence of a venous outflow stenosis or obstruction Full expansion of an appropriately sized standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment Exclusion Criteria: Subject has undergone an intervention (surgical or percutaneous) of the AVF/AVG <30 days from the date of the initial study procedure Subject has had a previous stent or stent graft placed in the venous outflow circuit ≤30 days from the date of the initial study procedure Active hemodialysis access is not in the arm A pseudoaneurysm is present within the target lesion Target lesion is in SVC, IJV, under the clavicle, across the elbow, in the needling segment of AVF or AVG anastomosis, located within a stent Lesions, other than the target lesion, in the venous outflow circuit with >30% stenosis Known or suspected infection of the hemodialysis access site and/or septicemia Permanent pacemaker or automated implantable cardioverter defibrillator (AICD) on the side with the target lesion Current central venous catheter for dialysis access Uncorrectable coagulation disorders Hypersensitivity to nickel titanium alloy The subject is enrolled in another investigational study The subject is unable or unwilling to comply with the protocol requirements Life expectancy is ≤ 12 months Subject cannot receive heparin or equivalent anticoagulant Allergy to radiographic contrast material which cannot be adequately premedicated Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant Subject's access is anticipated to be abandoned within 3 months Subject has a thoracic central vein obstruction that would lead to stent graft placement across the internal jugular vein Subject's hemodialysis access is thrombosed Active malignancy other than non-melanomatous skin cancer Any other condition deemed exclusionary in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm treated with investigational device WRAPSODY Stent Graft
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WRAPSODY Stent Graft<br>All subjects will receive treatment via WRAPSODY Stent Graft Placement. | Device: WRAPSODY Stent Graft Placement<br>* The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein<br>* Other names: Covered Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days | The total number of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death | 30 days | 
| Number of Participants With Target Lesion Primary Patency at 30 Days | The total number of subjects with Target Lesion Primary Patency at 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Target Lesion Primary Patency at 3 Months | The total number of subjects with Target Lesion Primary Patency at 3 months | 3 months | 
| Number of Participants With Target Lesion Primary Patency at 6 Months | The total number of subjects with Target Lesion Primary Patency at 6 months | 6 months | 
| Number of Participants With Target Lesion Primary Patency at 12 Months | The total number of subjects with Target Lesion Primary Patency at 12 months | 12 months | 
| Number of Participants With Assisted Target Lesion Primary Patency at 30 Days | The total number of subjects with Assisted Primary Patency of the Target Lesion at 30 days | 30 days | 
| Number of Participants With Assisted Target Lesion Primary Patency at 3 Months | The total number of subjects with Assisted Primary Patency of the Target Lesion at 3 months | 3 months | 
| Number of Participants With Assisted Target Lesion Primary Patency at 6 Months | The total number of subjects with Assisted Primary Patency of the Target Lesion at 6 months | 6 months | 
| Number of Participants With Assisted Target Lesion Primary Patency at 12 Months | The total number of subjects with Assisted Primary Patency of the Target Lesion at 12 months | 12 months | 
| Number of Participants With Access Circuit Primary Patency at 30 Days | The total number of subjects with Access Circuit Primary Patency at 30 days | 30 days | 
| Number of Participants With Access Circuit Primary Patency at 3 Months | The total number of subjects with Access Circuit Primary Patency at 3 months | 3 months | 
| Number of Participants With Access Circuit Primary Patency at 6 Months | The total number of subjects with Access Circuit Primary Patency at 6 months | 6 months | 
| Number of Participants With Access Circuit Primary Patency at 12 Months | The total number of subjects with Access Circuit Primary Patency at 12 months | 12 months | 
| Number of Participants With Assisted Access Circuit Primary Patency at 30 Days | The total number of subjects with Assisted Access Circuit Primary Patency at 30 days | 30 days | 
| Number of Participants With Assisted Access Circuit Primary Patency at 3 Months | The total number of subjects with Assisted Access Circuit Primary Patency at 3 months | 3 months | 
| Number of Participants With Assisted Access Circuit Primary Patency at 6 Months | The total number of subjects with Assisted Access Circuit Primary Patency at 6 months | 6 months | 
| Number of Participants With Assisted Access Circuit Primary Patency at 12 Months | The total number of subjects with Assisted Access Circuit Primary Patency at 12 months | 12 months | 
| Number of Participants With Clinical Success | The resumption of successful dialysis through existing access for at least one session following the initial study procedure | 30 days | 
| Number of Participants With Anatomic Success | Less than 30% residual stenosis immediately following the study procedure | Immediately following the study procedure | 
| Number of Participants With Procedural Success | The achievement of both clinical and anatomic success | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Stenosis, Dialysis, Venous Occlusion, Stent Graft