FLAIR™ Delivery System Study

Study Overview
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Brief Summary
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The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.

Official Title
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A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System

Conditions
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Constriction, Pathologic

Intervention / Treatment
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* Device: FLAIR™ Endovascular Stent Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is either a male or non-pregnant female ≥ 18 years old. The subject has been properly informed about the study per IRB requirements, and has signed and dated the IRB-approved ICF. The subject is willing to comply with the protocol requirements and can be contacted by telephone. The subject has a synthetic AV access graft located in an arm that has been implanted for > 30 days and has undergone at least one successful dialysis session prior to the index procedure. Angiographic evidence indicates that the subject has a stenosis of >50% located at the graft-vein anastomosis of the subject's synthetic AV access graft. The target lesion is estimated to be ≤ 7 cm in length by angiography prior to performance of any interventional procedures. The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased AV graft. Graft diameter at the deployment site is between 5 mm and 8 mm, as verified by angiography. Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty. Exclusion Criteria: The subject has a life expectancy of < 6 months. The presence of a previously placed stent and/or stent graft located in the treatment area. The treatment area is defined as the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein. The subject has an infected AV access graft or other infection. The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint. The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the outflow vein and synthetic AV access graft) that is > 90 degrees. The subject has an uncorrected blood coagulation disorder. The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated. Subject is currently enrolled or scheduled to be enrolled in other investigations that conflict with follow-up testing or confounds data in this trial. The subject has a known hypersensitivity to nickel-titanium.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLAIR Endovascular Stent Graft and Delivery System<br> | Device: FLAIR™ Endovascular Stent Graft<br>* The FLAIR™ Endovascular Stent Graft is designed to treat venous anastomotic stenoses of AV access grafts, providing both structural support of the site following angioplasty (stent), and a barrier to locally recurrent flow-limiting neointimal tissue growth (covering/graft).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success for Delivery | defined as deployment of the implant to the intended location, assessed at the time of the index procedure. | Measured at the time of implantation (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Device/Procedure-related Adverse Events(Safety of Delivery) | Device/Procedure-related adverse events from the index procedure through 30 days post procedure | Index Procedure to 30 days |