Arteriovenous Fistula
Conditions
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.
Interventions
DEVICECovera Vascular Covered Stent
This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria 1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. 2. Subject 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. 3. Subject must be willing to comply with the protocol requirements, including clinical and telephone follow-up. 4. Subject must have an upper extremity AV fistula that has undergone at least one successful dialysis session with two-needle cannulation, prior to the index procedure. 5. Subject must have angiographic evidence of a stenosis ≥ 50% (by visual estimation) located in the venous outflow of the AV access circuit and present with clinical or hemodynamic evidence of AV fistula dysfunction. 6. The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion. 7. The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0mm.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety through 30 days | 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. |
| Target Lesion Primary Patency (TLPP) | 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. |
| Access Circuit Primary Patency (ACPP) | 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. |
| Rate of Device and Procedure Related Adverse Events involving the access circuit | 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 | 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. |
| Total Number of Target Lesion Reinterventions | 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) | 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. |
| Index of Patency Function for Target Lesion | 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. |
| Post-Intervention Secondary Patency | 1, 3, 6, 12, 18, 24, and 36 months post index procedure | The interval after the index intervention until the access is abandoned. |
| Acute Technical Success for Stent Graft Placement | 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 | 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 |
Countries
United States
Outcome results
None listed