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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLAIR | Experimental | FLAIR Endovascular Stent Graft |
|
| PTA Only | Active Comparator | Percutaneous Transluminal Angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLAIR Endovascular Stent Graft | Device | Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziv Haskal, MD | University of Maryland Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Access Connections | Bamberg | South Carolina | 29003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27388566 | Result | Haskal ZJ, Saad TF, Hoggard JG, Cooper RI, Lipkowitz GS, Gerges A, Ross JR, Pflederer TA, Mietling SW. Prospective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study. J Vasc Interv Radiol. 2016 Aug;27(8):1105-1114.e3. doi: 10.1016/j.jvir.2016.05.019. Epub 2016 Jul 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FLAIR | FLAIR Endovascular Stent Graft FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft |
| FG001 | PTA Only | Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with hemodynamically significant stenosis fifty percent, clinical evidence of graft dysfunction (without thrombotic occlusion) at the synthetic AV access graft anastomosis, and who were selected from the Investigator's general subject population were eligible for participation in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | FLAIR | FLAIR Endovascular Stent Graft FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft |
| BG001 | PTA Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis). | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
|
From Index Procedure through 24 months of follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FLAIR | FLAIR Endovascular Stent Graft FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Van Vleet | Bard Peripheral Vascular | 1-800-321-4254 | John.VanVleet@CRBard.com |
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
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| PTA | Procedure | Treatment of stenoses with PTA only |
|
| 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 |
| Death |
|
| Adverse Experience |
|
Percutaneous Transluminal Angioplasty
PTA: Treatment of stenoses with PTA only
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PTA Only |
Percutaneous Transluminal Angioplasty PTA: Treatment of stenoses with PTA only |
|
|
| Primary | 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. | All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA. | Posted | Least Squares Mean | Standard Deviation | Months/intervention | 12 months |
|
|
|
| Primary | The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure. | Posted | Number | Number of Participants with Device and/o | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | reinterventions | Patient Follow-Up |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Number | Percentage of Participants | Patient Follow-Up |
|
|
|
| Secondary | 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. | Posted | Number | events | Patient Follow-Up |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants with serious | 12 months |
|
|
|
|
| Secondary | 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. | All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis). | Posted | Number | 95% Confidence Interval | proportion of participants | 24 months |
|
|
|
| Secondary | To Estimate Safety at 24 Months. | To estimate the percentage of participants without safety issues through 24 months. | Posted | Number | percentage of participants | 24 months |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | 24 month follow up |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | 24 months |
|
|
|
| Secondary | 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. | All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA. | Posted | Least Squares Mean | Standard Deviation | Months/intervention | 24 months |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | 6 month follow up |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | 6 month follow-up |
|
|
|
| Post-Hoc | Treatment Area Primary Patency (TAPP) at 12 Months. | TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months follow up |
|
|
|
| Post-Hoc | Treatment Area Primary Patency (TAPP) at 24 Months. | TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area. | Posted | Number | 95% Confidence Interval | proportion of participants | 24 months follow-up |
|
|
|
| 84 |
| 138 |
| 128 |
| 138 |
| EG001 | PTA Only | Percutaneous Transluminal Angioplasty PTA: Treatment of stenoses with PTA only | 87 | 132 | 127 | 132 |
| Congestive heart failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| hemotoma | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hemorrhage | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Pseudoaneurysm | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Significant arm or hand edema | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Stenosis requiring intervention | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Thrombotic occlusion | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Other | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Perforation | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Congestive heart failure | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Pseudoaneurysm | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Significant arm or hand edema | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Steal syndrome | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Stenosis requiring intervention | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Thrombotic occlusion | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vessel rupture | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Other | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |