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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-Center Clinical Study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis

Conditions
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Kidney Disease, End-Stage, End-stage Renal Disease, Arteriovenous Fistula

Intervention / Treatment
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* Device: EndoAVF Creation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoAVF<br> | Device: EndoAVF Creation<br>* Subjects will have an endoAVF created using the WavelinQ EndoAVF System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Patency | Subjects maintaining primary patency of the endoAVF | 6-months post index procedure | 
| Device- and procedure-related serious adverse events (SAE) | Freedom from device-related or procedure-related SAEs | 30-days post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Procedure Success | Successful endoAVF creation | Index procedure | 
| Cannulation Success | Successful 2-needle endoAVF cannulation | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure | 
| Primary Patency | Subjects maintaining primary patency of the endoAVF | 6-weeks, 3-, 12-, 18-, and 24-months post index procedure | 
| Assisted Primary Patency | Subjects maintaining assisted primary patency of the endoAVF | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure | 
| Secondary Patency | Subjects maintaining secondary patency of the endoAVF | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure | 
| Functional Patency | Interval of time from endoAVF cannulation success to involuntary access abandonment | through 24-months | 
| 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 | 
| CVC Exposure/Use |  | 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure | 
| Procedural Adjunctive Procedures | Adjunctive procedures performed at the time of the index procedure | Index Procedure | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EndoAVF