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Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT04261686•C. R. Bard

View on ClinicalTrials.gov

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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

•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.
+6 more criteria

Locations (11)

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

Key Dates

Start Date

July 3, 2020

Primary Completion Date

September 16, 2025

Completion Date

September 16, 2025

Last Updated

December 16, 2025

Enrollment

100

ACTUAL participants

Conditions

Arteriovenous Fistula

Interventions

Covera Vascular Covered Stent

DEVICE

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

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RECRUITINGNA

Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

NCT06422845

Arteriovenous Fistula Stenosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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