Clinical trial NCT04634916: Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Disease, End-Stage
End-stage Renal Disease
Arteriovenous Fistula
Keywords: EndoAVF
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional Cannulation Success
timeFrame: 6-months post index procedure
measure: Primary Patency
timeFrame: 6-months post index procedure
measure: Device- and procedure-related serious adverse events (SAE)
timeFrame: 30-days post index procedure
Secondary outcomes:
measure: Physiological Maturation
timeFrame: 2-weeks, 6-weeks, 6-months, and 24-months post index procedure
measure: Functional Maturation
timeFrame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
measure: Procedure Success
timeFrame: Index procedure
measure: Cannulation Success
timeFrame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
measure: Primary Patency
timeFrame: 6-weeks, 3-, 12-, 18-, and 24-months post index procedure
measure: Assisted Primary Patency
timeFrame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
measure: Secondary Patency
timeFrame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
measure: Functional Patency
timeFrame: through 24-months
measure: Functional Cannulation Success
timeFrame: 3-, 12-, 18-, and 24-months post index procedure
measure: CVC Exposure/Use
timeFrame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
measure: Procedural Adjunctive Procedures
timeFrame: Index Procedure
measure: Post Procedural Secondary Procedures
timeFrame: 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: California Institute of Renal Research
state: California
city: San Francisco
country: United States
facility: San Francisco Vein & Vascular
state: California
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists
state: Florida
city: Miami
country: United States
facility: Vascular and Interventional Specialists
state: Florida
city: Worcester
country: United States
facility: UMass Chan School of Medicine
state: Massachusetts
city: Saint Louis
country: United States
facility: SSM St. Mary's
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Hospital
state: New York
city: Raleigh
country: United States
facility: NC Nephrology
state: North Carolina
city: Butler
country: United States
facility: Butler Memorial Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Bluff City Vascular
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Eric Peden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany Medical College
name: Paul Kreienberg, MD
role: PRINCIPAL_INVESTIGATOR
References: