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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04634916
Other study ID # BPV-18-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 26, 2021
Est. completion date September 2024

Study information

Verified date November 2023
Source C. R. Bard
Contact Lindsay Downing
Phone 804-307-0924
Email lindsay.downing@bd.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 280
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
EndoAVF Creation
Subjects will have an endoAVF created using the WavelinQ EndoAVF System

Locations

Country Name City State
United States Albany Medical Center Albany New York
United States Butler Memorial Hospital Butler Pennsylvania
United States Baylor Scott & White Dallas Texas
United States Houston Methodist Houston Texas
United States University of Texas Health Science Center at Houston Houston Texas
United States California Institute of Renal Research La Jolla California
United States Radiology and Imaging Specialists Lakeland Florida
United States Vascular and Interventional Specialists Miami Florida
United States SSM St. Mary's Saint Louis Missouri
United States SUNY Upstate Medical University Hospital Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Primary Patency Subjects maintaining primary patency of the endoAVF 6-months post index procedure
Primary Device- and procedure-related serious adverse events (SAE) Freedom from device-related or procedure-related SAEs 30-days post index procedure
Secondary 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
Secondary 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
Secondary Procedure Success Successful endoAVF creation Index procedure
Secondary Cannulation Success Successful 2-needle endoAVF cannulation 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Secondary Primary Patency Subjects maintaining primary patency of the endoAVF 6-weeks, 3-, 12-, 18-, and 24-months post index procedure
Secondary Assisted Primary Patency Subjects maintaining assisted primary patency of the endoAVF 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Secondary Secondary Patency Subjects maintaining secondary patency of the endoAVF 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Secondary Functional Patency Interval of time from endoAVF cannulation success to involuntary access abandonment through 24-months
Secondary 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
Secondary CVC Exposure/Use 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Secondary Procedural Adjunctive Procedures Adjunctive procedures performed at the time of the index procedure Index Procedure
Secondary 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
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