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

Not Applicable

Recruiting

• Conditions: Kidney Disease, End-Stage; End-stage Renal Disease; Arteriovenous Fistula
• Interventions: Device: EndoAVF Creation

• Registration Number: NCT04634916
• Lead Sponsor: C. R. Bard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-18
• Study Start: 2021-03-26
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EndoAVF	EndoAVF Creation	-

Primary Outcome Measures

Name	Time	Method
Primary Patency	6-months post index procedure	Subjects maintaining primary patency of the endoAVF
Device- and procedure-related serious adverse events (SAE)	30-days post index procedure	Freedom from device-related or procedure-related SAEs
Functional Cannulation Success	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

Secondary Outcome Measures

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

Trial Locations

Locations (14)

NC Nephrology; 🇺🇸 Raleigh, North Carolina, United States

California Institute of Renal Research; 🇺🇸 La Jolla, California, United States

Bluff City Vascular; 🇺🇸 Memphis, Tennessee, United States

San Francisco Vein & Vascular; 🇺🇸 San Francisco, California, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Radiology and Imaging Specialists; 🇺🇸 Lakeland, Florida, United States

UMass Chan School of Medicine; 🇺🇸 Worcester, Massachusetts, United States

SSM St. Mary's; 🇺🇸 Saint Louis, Missouri, United States

Butler Memorial Hospital; 🇺🇸 Butler, Pennsylvania, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Vascular and Interventional Specialists; 🇺🇸 Miami, Florida, United States

Baylor Scott & White; 🇺🇸 Dallas, Texas, United States

SUNY Upstate Medical University Hospital; 🇺🇸 Syracuse, New York, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States