CompletedNot Applicable

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

United States100 participantsStarted 2020-07-03

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
. 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.
. Subject must be willing to comply with the protocol requirements, including clinical and telephone follow-up.
. 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.
. 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.
. The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion.
. The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0mm.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety through 30 days

Timeframe: Through 30 days following index procedure

Target Lesion Primary Patency (TLPP)

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months following post-index procedure

Access Circuit Primary Patency (ACPP)

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure

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.

Total Number of Arteriovenous (AV) Access Circuit Reinterventions

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure

Total Number of Target Lesion Reinterventions

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure

Index of Patency Function (IPF)

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure

Trial details

NCT IDNCT04261686

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-16

View on ClinicalTrials.gov More Arteriovenous Fistula trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
. 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.
. Subject must be willing to comply with the protocol requirements, including clinical and telephone follow-up.
. 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.
. 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.
. The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion.
. The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0mm.

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.

What they're measuring

Safety through 30 days

Timeframe: Through 30 days following index procedure

Target Lesion Primary Patency (TLPP)

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months following post-index procedure

Access Circuit Primary Patency (ACPP)

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure

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.

Total Number of Arteriovenous (AV) Access Circuit Reinterventions

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure

Total Number of Target Lesion Reinterventions

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure

Index of Patency Function (IPF)

Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure