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

Completed · Not applicable

Conditions studied: Arteriovenous Fistula

In brief

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.

Key facts

Study ID

NCT04261686

Run by

C. R. Bard

People needed

100

Starts

2020-07-03

Expected to finish

2025-09-16

Last updated by the study team

2025-12-16

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• 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.
• An aneurysm or pseudoaneurysm is present within the target lesion.
• The location of the target lesion would require the COVERATM Vascular Covered Stent be deployed across the elbow joint.
• The target lesion is located within a stent.
• 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").
• 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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