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

Overview

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.

Interventions

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

Primary outcome measures

• Functional Cannulation Success [Time frame: 6-months post index procedure]
• Primary Patency [Time frame: 6-months post index procedure]
• Device- and procedure-related serious adverse events (SAE) [Time frame: 30-days post index procedure]

Secondary outcome measures (12)

• Physiological Maturation [Time frame: 2-weeks, 6-weeks, 6-months, and 24-months post index procedure]
• Functional Maturation [Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
• Procedure Success [Time frame: Index procedure]
• Cannulation Success [Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
• Primary Patency [Time frame: 6-weeks, 3-, 12-, 18-, and 24-months post index procedure]
• Assisted Primary Patency [Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
• Secondary Patency [Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
• Functional Patency [Time frame: through 24-months]
• Functional Cannulation Success [Time frame: 3-, 12-, 18-, and 24-months post index procedure]
• CVC Exposure/Use [Time frame: 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]
• Procedural Adjunctive Procedures [Time frame: Index Procedure]
• Post Procedural Secondary Procedures [Time frame: 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 16 centers

• California Institute of Renal Research — La Jolla
• San Francisco Vein & Vascular — San Francisco
• First Coast Cardiovascular Institute Pa — Jacksonville
• Radiology and Imaging Specialists — Lakeland
• Vascular and Spine Institute Inc — Miami
• Kidney Care and Transplant Services of NE — Springfield
• Kidney Care & Transplant Services of New England — West Springfield
• UMass Chan School of Medicine — Worcester
• … and 8 more centers

Australia · 1 center

• Southern Adelaide Local Health Network — Bedford Park

Identifiers

NCT: NCT04634916 · BPV-18-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗