FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following Percutaneous Transluminal Angioplasty (PTA)) to PTA alone.

Official Title
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Prospective, Multi-Center, Randomized, Concurrently-Controlled Study of the FLUENCY® PLUS Endovascular Stent Graft in the Treatment of In-stent Restenosis in the Arteriovenous (AV) Access Venous Outflow Circuit (RESCUE)

Conditions
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Restenosis

Intervention / Treatment
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* Device: Fluency Plus Endovascular Stent Graft
* Device: Percutaneous Transluminal Angioplasty only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. Patient must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures. Patient must be willing to comply with the protocol requirements, including the follow-up procedures, and be contacted by telephone. Patient must have an AV access graft (implanted for ≥ 30 days) or mature fistula located in an arm, and must have undergone at least one successful dialysis session prior to the index procedure. Patient must have a previously-placed bare metal stent located in the venous outflow of the AV access circuit in which a ≥ 50% stenosis originates. The entire target lesion must be located in the restenosed bare metal stent and extend to no more than 3 cm outside of the bare metal stent. The target lesion must be ≤ 10 cm in length. After angiography, the operator must judge that the lesion is amenable to angioplasty. The reference vessel diameter at the restenosed bare metal stent must be between 5.0 mm and 12.0 mm. Additional stenotic lesions (≥ 50%) in the venous outflow that are > 3cm from the edge of the target lesion must be successfully treated (defined as < 30% residual stenosis) prior to the index procedure. Exclusion Criteria: The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure. The target lesion has a reference vessel diameter that is larger than 12.0 mm. The patient has an infected AV access graft/fistula or uncontrolled systemic infection. A pseudoaneurysm is present within the target lesion. The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed across the elbow joint. The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed at or across the segment of graft or fistula utilized for dialysis needle puncture (i.e., cannulation zone). The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft cross the cephalic arch (perpendicular portion of the cephalic vein in the region of the deltopectoral groove before its junction with the axillary vein). The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be placed in the Superior Vena Cava. The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft is placed across an angle that is greater than 90 degrees. The restenosed bare metal stent is fractured, as verified by angiography per institution's standard of care. The patient has a known uncontrolled blood coagulation disorder. The patient has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated. The patient has a known hypersensitivity to nickel-titanium. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. The patient is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

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: Fluency Plus Endovascular Stent Graft<br>Fluency Plus Endovascular Stent Graft | Device: Fluency Plus Endovascular Stent Graft<br>* Treatment of in-stent restenosis<br>|
| Active Comparator: Percutaneous Transluminal Angioplasty<br>Percutaneous Transluminal Angioplasty only | Device: Percutaneous Transluminal Angioplasty only<br>* Treatment of in-stent restenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 6 months |