Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System (CONNECT-AV)

August 7, 2026 updated by: C. R. Bard

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Southern Adelaide Local Health Network
        • Principal Investigator:
          • Christopher Delaney, MD
  • United States
    • California
      • La Jolla, California, United States, 92037
      • San Francisco, California, United States, 94117
        • Recruiting
        • San Francisco Vein & Vascular
        • Contact:
        • Principal Investigator:
          • Daniel Nathanson, MD
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • First Coast Cardiovascular Institute PA
        • Principal Investigator:
          • Yazan Khatib, MD
      • Lakeland, Florida, United States, 33801
      • Miami, Florida, United States, 33156
        • Active, not recruiting
        • Vascular and Spine Institute Inc
    • Massachusetts
      • Springfield, Massachusetts, United States, 01089
        • Recruiting
        • Kidney Care and Transplant Services of NE
        • Contact:
          • Lynn Pratt, BSN
          • Phone Number: (413) 747-1817
      • West Springfield, Massachusetts, United States, 01089
        • Recruiting
        • Kidney Care & Transplant Services of New England
        • Principal Investigator:
          • Aleksandr Kurbanov, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Chan School of Medicine
        • Contact:
        • Principal Investigator:
          • Dejah Judelson, MD
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Paul Kreienberg, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Completed
        • NC Nephrology
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital
        • Principal Investigator:
          • Mohamed Osman, MD
    • Pennsylvania
      • Butler, Pennsylvania, United States, 16001
        • Recruiting
        • Butler Memorial Hospital
        • Principal Investigator:
          • Brandon Repko, MD
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • Vascular Institute of Chattanooga
        • Principal Investigator:
          • Christopher Lesar, MD
      • Memphis, Tennessee, United States, 38104
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Aria Nazeri, MD
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
  3. Subject must be willing to comply with the protocol requirements, including clinical follow-up.
  4. 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.
  5. Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
  6. Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
  7. Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
  8. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.

Exclusion Criteria:

  1. The subject is in a hypercoagulable state.
  2. The subject has known bleeding diathesis.
  3. The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
  4. Known history of active intravenous drug abuse.
  5. "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
  6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
  7. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
  8. 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).
  9. 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.
  10. 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.
  11. The subject has central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned endoAVF creation.
  12. Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.
  13. Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.
  14. Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography.
  15. Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EndoAVF
Device: EndoAVF Creation
Subjects will have an endoAVF created using the WavelinQ EndoAVF System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Cannulation Success
Time Frame: 6-months post index procedure
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
6-months post index procedure
Primary Patency
Time Frame: 6-months post index procedure
Subjects maintaining primary patency of the endoAVF
6-months post index procedure
Device- and procedure-related serious adverse events (SAE)
Time Frame: 30-days post index procedure
Freedom from device-related or procedure-related SAEs
30-days post index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiological Maturation
Time Frame: 2-weeks, 6-weeks, 6-months, and 24-months post index procedure
Defined by duplex ultrasound flow in the brachial artery of at least 500ml/min and outflow vein diameter ≥ 4mm
2-weeks, 6-weeks, 6-months, and 24-months post index procedure
Functional Maturation
Time Frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Successful prescribed dialysis with 2-needle cannulation of the endoAVF for three continuous weeks
6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Procedure Success
Time Frame: Index procedure
Successful endoAVF creation
Index procedure
Cannulation Success
Time Frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Successful 2-needle endoAVF cannulation
6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Primary Patency
Time Frame: 6-weeks, 3-, 12-, 18-, and 24-months post index procedure
Subjects maintaining primary patency of the endoAVF
6-weeks, 3-, 12-, 18-, and 24-months post index procedure
Assisted Primary Patency
Time Frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Subjects maintaining assisted primary patency of the endoAVF
6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Secondary Patency
Time Frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Subjects maintaining secondary patency of the endoAVF
6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Functional Patency
Time Frame: through 24-months
Interval of time from endoAVF cannulation success to involuntary access abandonment
through 24-months
Functional Cannulation Success
Time Frame: 3-, 12-, 18-, and 24-months post index procedure
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
3-, 12-, 18-, and 24-months post index procedure
CVC Exposure/Use
Time Frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Procedural Adjunctive Procedures
Time Frame: Index Procedure
Adjunctive procedures performed at the time of the index procedure
Index Procedure
Post Procedural Secondary Procedures
Time Frame: 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Number of secondary procedures conducted after the index procedure, broken down to identify interventions and second stage procedures
2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Peden, MD, The Methodist Hospital Research Institute
  • Principal Investigator: Paul Kreienberg, MD, Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BPV-18-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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