Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft

Arteriovenous Fistula Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04261686
• Other study ID #: BDPI-19-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: November 18, 2025

Study information

• Verified date: April 2024
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 18, 2025
• Est. primary completion date: November 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Device:
• Covera Vascular Covered Stent
This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent

Locations

Country	Name	City	State
United States	Dallas Renal Group	Dallas	Texas
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	Yale University	New Haven	Connecticut
United States	Arizona Kidney Disease and Hypertension Center Medical Research Services	Phoenix	Arizona
United States	Providence Access Care	Providence	Rhode Island
United States	North Carolina Nephrology	Raleigh	North Carolina
United States	San Antonio Kidney and Disease Access Center	San Antonio	Texas
United States	Kidney Care & Transplant Services of New England	West Springfield	Massachusetts
United States	Chicago Access Care	Westmont	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through 30 days following index procedure
Primary	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.	1, 3, 6, 12, 18, 24, and 36 months following post-index procedure
Primary	Access Circuit Primary Patency (ACPP)	The interval following the index intervention until the next access thrombosis or repeated intervention.	1, 3, 6, 12, 18, 24, and 36 months post index procedure
Primary	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.	1, 3, 6, 12, 18, 24, and 36 months post index procedure.
Primary	Total Number of Arteriovenous (AV) Access Circuit Reinterventions	Number of reinterventions to the arteriovenous (AV) access circuit until access abandonment or through study completion.	1, 3, 6, 12, 18, 24, and 36 months post index procedure
Primary	Total Number of Target Lesion Reinterventions	Number of reinterventions to maintain target lesion patency	1, 3, 6, 12, 18, 24, and 36 months post index procedure
Primary	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.	1, 3, 6, 12, 18, 24, and 36 months post index procedure
Primary	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.	1, 3, 6, 12, 18, 24, and 36 months post index procedure
Primary	Post-Intervention Secondary Patency	The interval after the index intervention until the access is abandoned.	1, 3, 6, 12, 18, 24, and 36 months post index procedure
Primary	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.	At time of index procedure
Primary	Acute Procedural Success	Defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis	At time of index procedure