A Prospective, Multi-Center, Non-Randomized Clinical Study of the BARD® COVERA Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW) Post Approval Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arteriovenous Fistula
- Sponsor
- C. R. Bard
- Enrollment
- 100
- Locations
- 11
- Primary Endpoint
- Total Number of Target Lesion Reinterventions
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Clinical Exclusion Criteria
- •The subject is dialyzing with an AV graft.
- •The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
- •The hemodialysis access is located in the lower extremity.
- •The subject has an infected AV fistula or uncontrolled systemic infection.
- •The subject has a known uncontrolled blood coagulation/bleeding disorder.
- •The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
- •The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
- •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 subject 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.
Outcomes
Primary Outcomes
Total Number of Target Lesion Reinterventions
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Number of reinterventions to maintain target lesion patency
Index of Patency Function (IPF)
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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.
Safety through 30 days
Time Frame: Through 30 days following index procedure
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.
Access Circuit Primary Patency (ACPP)
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
The interval following the index intervention until the next access thrombosis or repeated intervention.
Target Lesion Primary Patency (TLPP)
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months following post-index procedure
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.
Rate of Device and Procedure Related Adverse Events involving the access circuit
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure.
Rate of device and procedure related adverse events (AEs) involving the access circuit.
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Number of reinterventions to the arteriovenous (AV) access circuit until access abandonment or through study completion.
Post-Intervention Secondary Patency
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
The interval after the index intervention until the access is abandoned.
Index of Patency Function for Target Lesion
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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.
Acute Technical Success for Stent Graft Placement
Time Frame: At time of index procedure
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.
Acute Procedural Success
Time Frame: At time of index procedure
Defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis