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Arteriovenous FistulaNCT04261686

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

A study testing Covera Vascular Covered Stent in people with Arteriovenous Fistula, run by C. R. Bard at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Arteriovenous Fistula
What is being tested?
Covera Vascular Covered Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
11 sitesUnited States
Study dates
3 Jul 2020to 16 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Dallas Renal Group

    Dallas, Texas, 75208

  • Michigan Vascular Center

    Flint, Michigan, 48507

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Minnesota Vascular and Surgery Center

    New Brighton, Minnesota, 55112

  • Yale University

    New Haven, Connecticut, 06511

  • Arizona Kidney Disease and Hypertension Center Medical Research Services

    Phoenix, Arizona, 85012

  • Providence Access Care

    Providence, Rhode Island, 02906

  • North Carolina Nephrology

    Raleigh, North Carolina, 27610

  • San Antonio Kidney and Disease Access Center

    San Antonio, Texas, 78216

  • Kidney Care & Transplant Services of New England

    West Springfield, Massachusetts, 01089

  • Chicago Access Care

    Westmont, Illinois, 60559

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Covera Vascular Covered Stent
Medical subject headings
Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Covera Vascular Covered StentDevice

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

Study groups in NCT04261686
Study groupRoleWhat they receive
COVERA Vascular Covered StentOtherCOVERA 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.
Receives: Device: Covera Vascular Covered Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through 30 days following index procedure

  2. 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.

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

  3. Access Circuit Primary Patency (ACPP)

    The interval following the index intervention until the next access thrombosis or repeated intervention.

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

  4. 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.

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

  5. Total Number of Arteriovenous (AV) Access Circuit Reinterventions

    Number of reinterventions to the arteriovenous (AV) access circuit until access abandonment or through study completion.

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

  6. Total Number of Target Lesion Reinterventions

    Number of reinterventions to maintain target lesion patency

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

  7. 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.

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

  8. 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.

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

  9. Post-Intervention Secondary Patency

    The interval after the index intervention until the access is abandoned.

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

  10. 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.

    Measured: At time of index procedure

  11. Acute Procedural Success

    Defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis

    Measured: At time of index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start3 Jul 2020
  3. Primary completion16 Sep 2025
  4. Study completion16 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04261686
Sponsor's protocol ID
BDPI-19-001
Status last verified
Dec 2025
First submitted
6 Feb 2020
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Dolmatch B, Saber T, Underwood M; and AVeNEW PAS trial investigators. Six-Month Outcomes from the Prospective, Multi-Center, Non-Randomized Clinical Study of the COVERA() Arterio VeNous (AV) Stent Graft in the Treatment of Stenosis in the VEnous OutfloW of AV Fistula Access Circuits (AVeNEW PAS). Cardiovasc Intervent Radiol. 2025 Apr;48(4):460-471. doi: 10.1007/s00270-024-03930-7. Epub 2025 Jan 9.

    PubMed 39789255

Questions about this trial

What is this clinical trial studying?

A study testing Covera Vascular Covered Stent in people with Arteriovenous Fistula, run by C. R. Bard at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety through 30 days (time frame: Through 30 days following index procedure). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04261686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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