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

End-stage Renal Disease Clinical Trial

— CONNECT-AV  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04634916
• Other study ID #: BPV-18-002
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• End-stage Renal Disease
• Fistula
• Kidney Disease, End-Stage
• Kidney Diseases
• Kidney Failure, Chronic

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