Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Study Overview
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Brief Summary
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This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule. IDE Number: G060250

Official Title
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Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular Graft in the Upper Extremity for Hemodialysis Vascular Access

Conditions
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Kidney Diseases, ESRD

Intervention / Treatment
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* Device: Vascular Wrap Paclitaxel-Eluting Mesh
* Device: Lifespan® ePTFE Vascular Graft
* Device: Lifespan® ePTFE Vascular Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be ≥ 18 years of age; if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0); be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity; have an outflow vein of greater than or equal to 3 mm in diameter; be able to effectively communicate with study personnel; be considered by the physician to be available for subsequent visits; be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration; allow representatives of the sponsor, designated CRO, Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records; sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; must agree to participate in protocol 014-VWAV07, a safety study to run consecutively for an additional 4 years or until Post-Market Approval (PMA), whichever is longer; and have the Lifespan® ePTFE Vascular Graft successfully implanted. Exclusion Criteria: pregnant, breast-feeding, or female of childbearing potential who do not agree to remain abstinent or to use a contraceptive method during the study period. Non-childbearing potential is defined as either post-menopausal (amenorrheic for at least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation or the absence of the uterus and/or ovaries; male of childbearing potential, who does not agree to remain abstinent or to use contraception to prevent fathering a child during the course of the study. Non-childbearing potential is defined as vasectomy or bilateral orchiectomy; a central venous stenosis on the ipsilateral side is documented; a hypercoagulable state is documented; life expectancy is less than one year; an organ transplant is expected within 6 months of test or control product (study products) placement; hypersensitivity to any component of the study products or procedural materials or medications is known; concurrently involved in another investigational study; a study product being investigated by others has been received within 30 days prior to randomization in this trial; the study product being studied in this trial has previously been received; uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening; currently receiving chemotherapy or radiation therapy; or placement of a new end-to-end arteriovenous anastomosis graft is required.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vascular Wrap and Graft<br>Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. The Vascular WrapTM Paclitaxel-Eluting Mesh is positioned on the vein and placed around the venous anastomosis to include both the toe and the heel of the anastomosis, and is sutured in place. | Device: Vascular Wrap Paclitaxel-Eluting Mesh<br>* 0.9 µg/mm^2 paclitaxel<br>* Other names: paclitaxel mesh;Device: Lifespan® ePTFE Vascular Graft<br>* vascular graft<br>|
| No Intervention: Lifespan® ePTFE Vascular Graft<br>Lifespan® ePTFE Vascular Graft Only: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. | Device: Lifespan® ePTFE Vascular Graft<br>* vascular graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-loss of Target Site Primary Patency | Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the time-to-loss of primary patency. Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis Access