Post-Approval Study for the FLAIR Endovascular Stent Graft

Study Overview
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Brief Summary
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The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.

Detailed Description
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The purpose of the study is to compare efficacy data on subjects randomized to treatment with percutaneous transluminal angioplasty (PTA) and the FLAIR™ Endovascular Stent Graft versus subjects randomized to treatment with PTA only.

Official Title
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A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft

Conditions
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Stenosis of Vascular Prosthetic Devices, Implants and Grafts

Intervention / Treatment
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* Device: FLAIR Endovascular Stent Graft
* Procedure: PTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be either a male or non-pregnant female greater than or equal to 21 years of age Subject is willing to comply with the protocol requirements and can be contacted by telephone Subject has a synthetic AV access graft located in an arm that has been implanted for greater than or equal to 30 days and has undergone at least one successful dialysis session prior to the index procedure Angiographic evidence (per the institution's standard) is available to indicate that the subject has a stenosis greater than or equal to 50% located at the graft-vein anastomosis of subject's synthetic AV access graft The target lesion is estimated to be less than or equal to 7 cm in length (by angiography) 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 the non-diseased AV graft Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty Graft diameter at the deployment site is between 5 mm and 8 mm as verified by angiography Exclusion Criteria: The subject has a life expectancy of < 25 months. The target lesion has had a corresponding thrombosis treated less than or equal to 7 days prior to the index procedure. A previously placed stent and/or stent graft located in the treatment area is present. Treatment area includes 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 uncontrolled systemic infection. The presence of additional lesion(s) in the access circuit less than or equal to 3 cm from the edges of the target lesion that was treated less than or equal to 30 days prior to index procedure. The presence of additional lesion(s) in the access circuit > 3 cm from the edges of the primary lesion that are greater than or equal to 30% stenosed. Note: Subjects may be included if the additional lesions(s) can be successfully treated with a final residual stenosis of < 30% prior to the index procedure. The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint (radiographically identified by a combination of the humeroulnar joint and the humeroradial joint). The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the inflow vein and synthetic AV access graft) that is > 90 degrees. The subject has an uncontrolled blood coagulation disorder. The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated. The subject has a known hypersensitivity to nickel-titanium. Subjects who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLAIR<br>FLAIR Endovascular Stent Graft | Device: FLAIR Endovascular Stent Graft<br>* Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft<br>|
| Active Comparator: PTA Only<br>Percutaneous Transluminal Angioplasty | Procedure: PTA<br>* Treatment of stenoses with PTA only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention. | To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure. | 12 months | 
| The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure. | The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis. | 12 months | 
| The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure | The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. | Patient Follow-Up | 
| Post-Intervention Assisted Primary Patency at 12 Months | Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit. | 12 months | 
| Post-intervention Secondary Patency (PSP) at 12 Months | Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis. | 12 months | 
| Procedural Success | Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success. | Patient Follow-Up | 
| Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure | The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program. | Patient Follow-Up | 
| Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months | Serious Adverse Events at 12 months are reported for all 270 subjects. | 12 months | 
| Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention. | Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months. | 24 months | 
| To Estimate Safety at 24 Months. | To estimate the percentage of participants without safety issues through 24 months. | 24 months | 
| Post-Intervention Assisted Primary Patency at 24 Months | Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit. | 24 month follow up | 
| Post-intervention Secondary Patency at 24 Months | Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis. | 24 months | 
| Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months. | The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis. | 24 months | 
| Post-Intervention Assisted Primary Patency at 6 Months | Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit. | 6 month follow up | 
| Post-intervention Secondary Patency at 6 Months | Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis. | 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Vascular Prosthesis, Stenosis, End-stage Renal Disease (ESRD)