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

NCT04634916 | Recruiting FDA Device

• 1 other identifier: BPV-18-002
• Study Type: interventional
• Target: 280
• Locations: 2 countries
• Sites: 17

Brief 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.

Conditions

Kidney Disease, End-Stage; End-stage Renal Disease; Arteriovenous Fistula

Keywords

EndoAVF

Outcome Measures

Primary Outcomes (3)

• 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

  6-months post index procedure

• Primary Patency

  Subjects maintaining primary patency of the endoAVF

  6-months post index procedure

• Device- and procedure-related serious adverse events (SAE)

  Freedom from device-related or procedure-related SAEs

  30-days post index procedure

Secondary Outcomes (12)

• Physiological Maturation

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

• Functional Maturation

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

• Procedure Success

  Index procedure

• Cannulation Success

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

• Primary Patency

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

Study Arms (1)

EndoAVF

EXPERIMENTAL

Device: EndoAVF Creation

Interventions

EndoAVF Creation DEVICE

Subjects will have an endoAVF created using the WavelinQ EndoAVF System

EndoAVF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (17)

California Institute of Renal Research

La Jolla, California, 92037, United States

RECRUITING

San Francisco Vein & Vascular

San Francisco, California, 94117, United States

RECRUITING

First Coast Cardiovascular Institute Pa

Jacksonville, Florida, 32256, United States

RECRUITING

Radiology and Imaging Specialists

Lakeland, Florida, 33801, United States

RECRUITING

Vascular and Spine Institute Inc

Miami, Florida, 33156, United States

ACTIVE NOT RECRUITING

Kidney Care and Transplant Services of NE

Springfield, Massachusetts, 01089, United States

RECRUITING

Kidney Care & Transplant Services of New England

West Springfield, Massachusetts, 01089, United States

RECRUITING

UMass Chan School of Medicine

Worcester, Massachusetts, 01655, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

NC Nephrology

Raleigh, North Carolina, 27609, United States

COMPLETED

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

Butler Memorial Hospital

Butler, Pennsylvania, 16001, United States

RECRUITING

Vascular Institute of Chattanooga

Chattanooga, Tennessee, 37421, United States

RECRUITING

Bluff City Vascular

Memphis, Tennessee, 38104, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Southern Adelaide Local Health Network

Bedford Park, South Australia, 5042, Australia

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• Eric Peden, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Paul Kreienberg, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Anderson

CONTACT

+16028305413; Crystal.Anderson@bd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 18, 2020
• Study Start: March 26, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); AU (1)