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

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: Recruiting
• Conditions: Arteriovenous Fistula; End-stage Renal Disease; Kidney Disease, End-Stage
• Intervention / Treatment: Device: EndoAVF Creation

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay Downing; Phone Number: 804-307-0924; Email: lindsay.downing@bd.com

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • California Institute of Renal Research
      • Contact: Karina Maldonado; Email: kmaldonado@balboaunited.org
  • Florida
    • Lakeland, Florida, United States, 33801
      • Recruiting
      • Radiology and Imaging Specialists
      • Contact: Eve Johnson; Email: ejohnson@risimaging.com
    • Miami, Florida, United States, 33156
      • Recruiting
      • Vascular and Interventional Specialists
      • Contact: Dana Biton; Email: dana.s.biton@gmail.com
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Recruiting
      • SSM St. Mary's
      • Contact: Christi Ozenkoski; Email: christiozenkoski@gmail.com
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Stephanie Collins; Email: collins7@amc.edu
      • Principal Investigator: Paul Kreienberg, MD
    • Syracuse, New York, United States, 13210
      • Recruiting
      • SUNY Upstate Medical University Hospital
      • Contact: Wei Li, MD, RPVI, RVT; Phone Number: 315-464-8272 opt 1
      • Principal Investigator: Wei Li, MD, RPVI, RVT
  • Pennsylvania
    • Butler, Pennsylvania, United States, 16001
      • Recruiting
      • Butler Memorial Hospital
      • Contact: Jenny Kopp, RN; Phone Number: 833-808-2273; Email: Jenny.Kopp@butlerhealthsystem.org
      • Principal Investigator: Brandon Repko, MD
  • Texas
    • Dallas, Texas, United States, 75226
      • Recruiting
      • Baylor Scott & White
      • Contact: JaKarsha Culton; Email: jakarsha.culton@bswhealth.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center at Houston
      • Principal Investigator: Ahmed Kamel Abdel Aal, MD
      • Contact: Usha Menon; Email: Usha.N.Menon@uth.tmc.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist
      • Contact: Ruth Medcalf; Email: rmedcalf@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EndoAVF	Device: EndoAVF Creation; Subjects will have an endoAVF created using the WavelinQ EndoAVF System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Maturation	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	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	Successful endoAVF creation	Index procedure
Cannulation Success	Successful 2-needle endoAVF cannulation	6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Primary Patency	Subjects maintaining primary patency of the endoAVF	6-weeks, 3-, 12-, 18-, and 24-months post index procedure
Assisted Primary Patency	Subjects maintaining assisted primary patency of the endoAVF	6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Secondary Patency	Subjects maintaining secondary patency of the endoAVF	6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Functional Patency	Interval of time from endoAVF cannulation success to involuntary access abandonment	through 24-months
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	3-, 12-, 18-, and 24-months post index procedure
CVC Exposure/Use		6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Procedural Adjunctive Procedures	Adjunctive procedures performed at the time of the index procedure	Index Procedure
Post Procedural Secondary Procedures	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

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Eric Peden, MD, The Methodist Hospital Research Institute; Principal Investigator: Paul Kreienberg, MD, Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: EndoAVF
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Disease Attributes; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID 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