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The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.
This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following Percutaneous Transluminal Angioplasty (PTA)) to PTA alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluency Plus Endovascular Stent Graft | Experimental | Fluency Plus Endovascular Stent Graft |
|
| Percutaneous Transluminal Angioplasty | Active Comparator | Percutaneous Transluminal Angioplasty only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluency Plus Endovascular Stent Graft | Device | Treatment of in-stent restenosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months. | Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success. | 6 months |
| Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions. | Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions. | Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abigail Falk, M.D. | Access Center of New Jersey | Principal Investigator |
| Ivan Maya, MD | Nephrology Associates of Central Florida | Principal Investigator |
| Alexander Yevzlin, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Radiology Dept | Birmingham | Alabama | 35294 | United States | ||
| Southwest Kidney Institute Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluency | Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis |
| FG001 | PTA Only | PTA only: Treatment of in-stent restenosis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Percutaneous Transluminal Angioplasty only | Device | Treatment of in-stent restenosis |
|
| 6 months |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Arizona Kidney Disease & Hypertension Center-Surgery Center | Phoenix | Arizona | 85012 | United States |
| Capital Nephrology Access Center | Sacramento | Arizona | 95815 | United States |
| Angiocare LLC w/Renal Care Associates PC | Tucson | Arizona | 85719 | United States |
| Greater Long Beach Vascular Access Center | Bellflower | California | 90706 | United States |
| Ladenheim Dialysis Access Centers | Fresno | California | 93710 | United States |
| American Access Care Connecticut Image Guided Surgery | Fairfield | Connecticut | 06825 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | United States |
| Vascular & Interventional Care Center | Augusta | Georgia | 30901 | United States |
| Savannah Vascular Surgery | Savannah | Georgia | 31404 | United States |
| MakrisMD, LLC, d/b/a Chicago Access Care | Hinsdale | Illinois | 60521 | United States |
| The Vascular Access Center | West Springfield | Massachusetts | 01089 | United States |
| ProHEALTH Care Associates LLP | Lake Success | New York | 11042 | United States |
| Capital Access Center | Raleigh | North Carolina | 27610 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Providence Access Care | Providence | Rhode Island | 02906 | United States |
| Premeire Vascular Access and Imaging Center | Knoxsville | Tennessee | 37919 | United States |
| Renal Associates, P.A. Research Division | San Antonio | Texas | 78215 | United States |
| American Access Care of Richmond | Richmond | Virginia | 23230 | United States |
| University of Wisconsin School of Medicine & Public Health | Madison | Wisconsin | 53792 | United States |
| Midwest Nephrology Associates Vascular Access Center | Milwaukee | Wisconsin | 53215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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275 subjects were enrolled but, the primary effectiveness endpoint was statistically tested with 220 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluency | Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis |
| BG001 | PTA Only | PTA only: Treatment of in-stent restenosis |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months. | Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success. | Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months). | Posted | Number | 95% Confidence Interval | % of subjects with successful ACPP | 6 months |
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| Primary | Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions. | Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days. | Safety rates measured for the randomized subjects population (both AV Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days. | Posted | Number | 95% Confidence Interval | % of subjects free from safety events | 30 days |
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| Secondary | Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions. | Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success. | Posted | Number | 95% Confidence Interval | % of subjects with successful PLP | 6 months |
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all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
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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 | Fluency | Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis | 4 | 128 | 11 | 128 | ||
| EG001 | PTA Only | PTA only: Treatment of in-stent restenosis | 4 | 137 | 8 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection in the AVF venous cannulation site | Infections and infestations | Any Adverse Event | Non-systematic Assessment |
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| infection of the old stent in the fistula | Infections and infestations | Any Adverse Event | Non-systematic Assessment |
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| vessel rupture | Blood and lymphatic system disorders | Any Adverse Event | Non-systematic Assessment |
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| ventricular fibrillation | Cardiac disorders | Any Adverse Event | Non-systematic Assessment |
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| arm or hand edema | Musculoskeletal and connective tissue disorders | Any Adverse Event | Non-systematic Assessment |
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| rash on arm due to allergic reaction to unknown source | Skin and subcutaneous tissue disorders | Any Adverse Event | Non-systematic Assessment |
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| fever/cellulitis of both legs/sepsis | Infections and infestations | Any Adverse Event | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Blood and lymphatic system disorders | Any Adverse Event | Non-systematic Assessment |
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| Infection | Infections and infestations | Any Adverse Event | Non-systematic Assessment |
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| Pain | Injury, poisoning and procedural complications | Any Adverse Event | Non-systematic Assessment |
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| Arm or Hand Edema | Musculoskeletal and connective tissue disorders | Any Adverse Event | Non-systematic Assessment |
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| Pseudoaneurysm | Vascular disorders | Any Adverse Event | Non-systematic Assessment |
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| Vessel Rupture | Vascular disorders | Any Adverse Event | Non-systematic Assessment |
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| Allergic reaction. to uncertain source; rash on right arm | Infections and infestations | Any Adverse Event | Non-systematic Assessment |
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| Fever/cellulitis of both legs/sepsis | Infections and infestations | Any Adverse Event | Non-systematic Assessment |
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| Infolded covered stent | Vascular disorders | Any Adverse Event |
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| Prolonged Bleeding | Blood and lymphatic system disorders | Any Adverse Event | Non-systematic Assessment |
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| Ventricular Fibrillation | Cardiac disorders | Any Adverse Event | Non-systematic Assessment |
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| hemoptysis | Blood and lymphatic system disorders | Any Adverse Event | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josh Smale, Associate Director Clinical Affairs | Bard Peripheral Vascular | (480) 603-8140 | Josh.Smale@crbard.com |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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