Clinical trial NCT04261686: Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arteriovenous Fistula
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 Exclusion Criteria

1. The subject is dialyzing with an AV graft.
2. The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
3. The hemodialysis access is located in the lower extremity.
4. The subject has an infected AV fistula or uncontrolled systemic infection.
5. The subject has a known uncontrolled blood coagulation/bleeding disorder.
6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
7. The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
8. 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.
9. 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.
10. Additional stenotic lesions (≥ 50%) in the venous outflow that are \> 3cm from the edge of the target lesion and are not successfully treated (defined as ≤ 30% residual stenosis) prior to treating the target lesion.
11. An aneurysm or pseudoaneurysm is present within the target lesion.
12. The location of the target lesion would require the COVERATM Vascular Covered Stent be deployed across the elbow joint.
13. The target lesion is located within a stent.
14. The location of the target lesion would require that the COVERA™ Vascular Covered Stent be deployed at or across the segment of fistula utilized for dialysis needle puncture (i.e., "cannulation zone").
15. The location of the target lesion would require that the COVERA™ Vascular Covered Stent be placed in the central veins (subclavian, brachiocephalic, Superior Vena Cava (SVC)) or under the clavicle at the thoracic outlet.
16. There is incomplete expansion of an appropriately sized angioplasty balloon to its expected profile, in the operator's judgment, during primary angioplasty at the target lesion.

Primary outcomes:
measure: Safety through 30 days
timeFrame: Through 30 days following index procedure
measure: Target Lesion Primary Patency (TLPP)
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months following post-index procedure
measure: Access Circuit Primary Patency (ACPP)
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
measure: Rate of Device and Procedure Related Adverse Events involving the access circuit
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure.
measure: Total Number of Arteriovenous (AV) Access Circuit Reinterventions
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
measure: Total Number of Target Lesion Reinterventions
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
measure: Index of Patency Function (IPF)
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
measure: Index of Patency Function for Target Lesion
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
measure: Post-Intervention Secondary Patency
timeFrame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
measure: Acute Technical Success for Stent Graft Placement
timeFrame: At time of index procedure
measure: Acute Procedural Success
timeFrame: At time of index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Kidney Disease and Hypertension Center Medical Research Services
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Westmont
country: United States
facility: Chicago Access Care
state: Illinois
city: West Springfield
country: United States
facility: Kidney Care & Transplant Services of New England
state: Massachusetts
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: New Brighton
country: United States
facility: Minnesota Vascular and Surgery Center
state: Minnesota
city: Raleigh
country: United States
facility: North Carolina Nephrology
state: North Carolina
city: Providence
country: United States
facility: Providence Access Care
state: Rhode Island
city: Dallas
country: United States
facility: Dallas Renal Group
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney and Disease Access Center
state: Texas
Study officials:
affiliation: The Palo Alto Medical Foundation
name: Bart Dolmatch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: