The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit.
Prospective, multi-center, non-randomized clinical study designed to assess the long-term safety and effectiveness of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the AV access circuit of hemodialysis subjects dialyzing with an arteriovenous (AV) fistula.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent
Arizona Kidney Disease and Hypertension Center Medical Research Services
Phoenix, Arizona, United States
Yale University
New Haven, Connecticut, United States
Chicago Access Care
Westmont, Illinois, United States
Safety through 30 days
Freedom from any adverse event(s), localized or systemic, that reasonably suggest the involvement of the AV access circuit that require or result in any of the following alone or in combination: additional interventions, in-patient hospitalization or prolongation of an existing hospitalization; or death.
Time frame: Through 30 days following index procedure
Target Lesion Primary Patency (TLPP)
The interval following the index intervention until the next clinically driven reintervention at or adjacent to the original treatment site, or until the extremity is abandoned for permanent access.
Time frame: 1, 3, 6, 12, 18, 24, and 36 months following post-index procedure
Access Circuit Primary Patency (ACPP)
The interval following the index intervention until the next access thrombosis or repeated intervention.
Time frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Rate of Device and Procedure Related Adverse Events involving the access circuit
Rate of device and procedure related adverse events (AEs) involving the access circuit.
Time frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure.
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Number of reinterventions to the arteriovenous (AV) access circuit until access abandonment or through study completion.
Time frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Total Number of Target Lesion Reinterventions
Number of reinterventions to maintain target lesion patency
Time frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kidney Care & Transplant Services of New England
West Springfield, Massachusetts, United States
Michigan Vascular Center
Flint, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Minnesota Vascular and Surgery Center
New Brighton, Minnesota, United States
North Carolina Nephrology
Raleigh, North Carolina, United States
Providence Access Care
Providence, Rhode Island, United States
Dallas Renal Group
Dallas, Texas, United States
...and 1 more locations
Index of Patency Function (IPF)
Time from the index study procedure to study completion or access 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.
Time frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Index of Patency Function for Target Lesion
Time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis.
Time frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Post-Intervention Secondary Patency
The interval after the index intervention until the access is abandoned.
Time frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Acute Technical Success for Stent Graft Placement
Defined as the successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure.
Time frame: At time of index procedure
Acute Procedural Success
Defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis
Time frame: At time of index procedure