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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
275
Treatment of in-stent restenosis
Treatment of in-stent restenosis
University of Alabama Radiology Dept
Birmingham, Alabama, United States
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.
Time frame: 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.
Time frame: 30 days
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.
Time frame: 6 months
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