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Kidney Disease, End-StageCONNECT-AVNCT04634916

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

A study testing EndoAVF Creation in people with Kidney Disease, End-Stage and End-stage Renal Disease, run by C. R. Bard at 17 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EndoAVF Creation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
17 sitesin 2 countries
Study dates
26 Mar 2021to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
  • 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 willing to comply with the protocol requirements, including clinical follow-up.
  • Subjects who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis.
  • Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
  • Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
  • Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
  • At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.

Who cannot join

  • The subject is in a hypercoagulable state.
  • The subject has known bleeding diathesis.
  • The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
  • Known history of active intravenous drug abuse.
  • "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
  • The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
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  • The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
  • Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).
  • 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.
  • The subject has central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned endoAVF creation.
  • Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.
  • Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.
  • Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography.
  • Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.

Trial locations and contacts

17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Crystal Anderson contact

+16028305413

Crystal.Anderson@bd.com

17 sites in 2 countries

United States16 sites, 14 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Stephanie Collins, collins7@amc.edu

    Paul Kreienberg, MD

    Recruiting

  • Butler Memorial Hospital

    Butler, Pennsylvania, 16001

    Jenny Kopp, RN, 1-833-808-2273, Jenny.Kopp@butlerhealthsystem.org

    Brandon Repko, MD

    Recruiting

  • Vascular Institute of Chattanooga

    Chattanooga, Tennessee, 37421

    Christopher Lesar, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Aria Nazeri, MD

    Recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Ruth Medcalf, rmedcalf@houstonmethodist.org

    Recruiting

  • First Coast Cardiovascular Institute Pa

    Jacksonville, Florida, 32256

    Yazan Khatib, MD

    Recruiting

  • California Institute of Renal Research

    La Jolla, California, 92037

    Karina Maldonado, kmaldonado@balboaunited.org

    Recruiting

  • Radiology and Imaging Specialists

    Lakeland, Florida, 33801

    Eve Johnson, ejohnson@risimaging.com

    Recruiting

  • Bluff City Vascular

    Memphis, Tennessee, 38104

    Terry Litchfield, (901) 726-1130, terryflitchfield@gmail.com

    Recruiting

  • Vascular and Spine Institute Inc

    Miami, Florida, 33156

    Active, not recruiting

  • NC Nephrology

    Raleigh, North Carolina, 27609

    Completed

  • San Francisco Vein & Vascular

    San Francisco, California, 94117

    Patti O'Kelly, 415-230-2421, patti.okelly@bassmedicalgroup.com

    Daniel Nathanson, MD

    Recruiting

  • Kidney Care and Transplant Services of NE

    Springfield, Massachusetts, 01089

    Lynn Pratt, BSN, (413) 747-1817

    Recruiting

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

    Mohamed Osman, MD

    Recruiting

  • Kidney Care & Transplant Services of New England

    West Springfield, Massachusetts, 01089

    Aleksandr Kurbanov, MD

    Recruiting

  • UMass Chan School of Medicine

    Worcester, Massachusetts, 01655

    Mollynda McArthur, 774-443-0872, mollynda.mcarthur2@umassmed.edu

    Dejah Judelson, MD

    Recruiting

Other trials in United States

Australia1 site, 1 recruiting

  • Southern Adelaide Local Health Network

    Bedford Park, South Australia, 5042

    Christopher Delaney, MD

    Recruiting

Other trials in Australia

About this study

Official title: A Prospective, Multi-Center Clinical Study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis

A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.

Being tested
EndoAVF Creation
Keywords
EndoAVF
Medical subject headings
Kidney Failure, Chronic, Arteriovenous Fistula

What participants receive

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

  • EndoAVF CreationDevice

    Subjects will have an endoAVF created using the WavelinQ EndoAVF System

Study groups in NCT04634916
Study groupRoleWhat they receive
EndoAVFExperimentalNot described
Receives: Device: EndoAVF Creation

What is being measured

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

  1. Functional Cannulation Success

    The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period

    Measured: 6-months post index procedure

  2. Primary Patency

    Subjects maintaining primary patency of the endoAVF

    Measured: 6-months post index procedure

  3. Device- and procedure-related serious adverse events (SAE)

    Freedom from device-related or procedure-related SAEs

    Measured: 30-days post index procedure

Secondary outcomes (12)

  1. Physiological Maturation

    Defined by duplex ultrasound flow in the brachial artery of at least 500ml/min and outflow vein diameter ≥ 4mm

    Measured: 2-weeks, 6-weeks, 6-months, and 24-months post index procedure

  2. Functional Maturation

    Successful prescribed dialysis with 2-needle cannulation of the endoAVF for three continuous weeks

    Measured: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

  3. Procedure Success

    Successful endoAVF creation

    Measured: Index procedure

  4. Cannulation Success

    Successful 2-needle endoAVF cannulation

    Measured: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

  5. Primary Patency

    Subjects maintaining primary patency of the endoAVF

    Measured: 6-weeks, 3-, 12-, 18-, and 24-months post index procedure

  6. Assisted Primary Patency

    Subjects maintaining assisted primary patency of the endoAVF

    Measured: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

  7. Secondary Patency

    Subjects maintaining secondary patency of the endoAVF

    Measured: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

  8. Functional Patency

    Interval of time from endoAVF cannulation success to involuntary access abandonment

    Measured: through 24-months

  9. Functional Cannulation Success

    The percentage of subjects dialyzed using successful 2-needle access of the endoAVF for at least 75% of dialysis sessions over a continuous 28-day period

    Measured: 3-, 12-, 18-, and 24-months post index procedure

  10. CVC Exposure/Use

    Measured: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

  11. Procedural Adjunctive Procedures

    Adjunctive procedures performed at the time of the index procedure

    Measured: Index Procedure

  12. Post Procedural Secondary Procedures

    Number of secondary procedures conducted after the index procedure, broken down to identify interventions and second stage procedures

    Measured: 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post 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 posted18 Nov 2020
  2. Study start26 Mar 2021
  3. Primary completionJun 2027 (estimated)
  4. Study completionSep 2027 (estimated)

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
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634916
Sponsor's protocol ID
BPV-18-002
Acronym
CONNECT-AV
Status last verified
Mar 2026
First submitted
9 Nov 2020
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EndoAVF Creation in people with Kidney Disease, End-Stage and End-stage Renal Disease, run by C. R. Bard at 17 sites in 2 countries.

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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Australia. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Crystal Anderson (+16028305413, Crystal.Anderson@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Cannulation Success (time frame: 6-months post index procedure). The study lists 3 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 NCT04634916.

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 10 Aug 2026.

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