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

Not Applicable

Active, not recruiting

• Conditions: Arteriovenous Fistula
• Interventions: Device: Covera Vascular Covered Stent

• Registration Number: NCT04261686
• Lead Sponsor: C. R. Bard

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.

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Study Start: 2020-07-03
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-11-18
• Study Completion: 2025-11-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVERA Vascular Covered Stent	Covera Vascular Covered Stent	COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of hemodialysis subjects dialyzing with an AV fistula.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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

Trial Locations

Locations (11)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

San Antonio Kidney and Disease Access Center; 🇺🇸 San Antonio, Texas, United States

Chicago Access Care; 🇺🇸 Westmont, Illinois, United States

Michigan Vascular Center; 🇺🇸 Flint, Michigan, 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

Minnesota Vascular and Surgery Center; 🇺🇸 New Brighton, Minnesota, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Kidney Care & Transplant Services of New England; 🇺🇸 West Springfield, Massachusetts, United States

Arizona Kidney Disease and Hypertension Center Medical Research Services; 🇺🇸 Phoenix, Arizona, United States