NCT04634916RecruitingNot Applicable
A Prospective, Multi-Center Clinical Study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis
C. R. Bard17 sites in 2 countries220 target enrollmentStarted: March 26, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 17
- Primary Endpoint
- Primary Patency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- •Subject must be willing to comply with the protocol requirements, including clinical follow-up.
- •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.
- •Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
- •Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
- •Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
- •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
- •The subject is in a hypercoagulable state.
- •The subject has known bleeding diathesis.
- •The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator.
- •Known history of active intravenous drug abuse.
- •"Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
- •The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
- •The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
- •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).
- •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.
- •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.
- •The subject has central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned endoAVF creation.
- •Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.
- •Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.
- •Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography.
- •Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.
Arms & Interventions
EndoAVF
Experimental
Intervention: EndoAVF Creation (Device)
Outcomes
Primary Outcomes
Primary Patency
Time Frame: 6-months post index procedure
Subjects maintaining primary patency of the endoAVF
Device- and procedure-related serious adverse events (SAE)
Time Frame: 30-days post index procedure
Freedom from device-related or procedure-related SAEs
Functional Cannulation Success
Time Frame: 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 Outcomes
- Functional Cannulation Success(3-, 12-, 18-, and 24-months post index procedure)
- Post Procedural Secondary Procedures(2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Functional Patency(through 24-months)
- Assisted Primary Patency(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Cannulation Success(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Procedure Success(Index procedure)
- Primary Patency(6-weeks, 3-, 12-, 18-, and 24-months post index procedure)
- Procedural Adjunctive Procedures(Index Procedure)
- Physiological Maturation(2-weeks, 6-weeks, 6-months, and 24-months post index procedure)
- Functional Maturation(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- Secondary Patency(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
- CVC Exposure/Use(6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure)
Investigators
Study Sites (17)
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