The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation

Study Overview
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Brief Summary
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This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in patients who require a vascular access for hemodialysis (HD).

Detailed Description
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The purpose of this clinical investigation is to provide clinical evidence to further demonstrate reasonable assurance of safety and effectiveness of the WavelinQ™ EndoAVF System when used for endovascular arteriovenous fistula (endoAVF) creations. Treated participants will be followed for 24-months post index procedure.

Official Title
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The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation

Conditions
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AV Fistula, Kidney Failure, End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Insufficiency, Kidney Disease, Chronic, Fistulas Arteriovenous

Intervention / Treatment
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* Device: WavelinQ™ EndoAVF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant must: Be able to comprehend, voluntarily sign and date the informed consent form (ICF) prior to collection of clinical investigation data or performance of clinical investigation procedures (or where allowable the participant's legally authorized representative (LAR) on behalf of the participant). Be able to and willing to comply with the CIP requirements, including clinical follow-up. Be male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient (≥ 24 months) to allow for completion of all clinical investigation procedures. Have established, non-reversible kidney failure, who are currently on HD at screening or are in need of a vascular access for HD as determined by the referring clinician. Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or angiography. A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography. Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or authorized designee). At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or angiography that is in communication with the target creation site via a proximal forearm perforating vein. Exclusion Criteria: The participant must not have: Active or nontreated hypercoagulable state. Known bleeding diathesis. Insufficient cardiac output to support the maturation and use of an AVF in the opinion of the PI (or authorized designee). Known history of or current active intravenous drug abuse. A planned major surgical procedure within 6 months following index procedure or major surgery, in the opinion of the PI (or authorized designee), within 30 days prior to index procedure. Known allergy or hypersensitivity to contrast media which cannot be adequately treated with pre-medication. Known adverse effects to sedation and / or anesthesia which cannot be adequately treated with pre-medication. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and / or White Blood Cell (WBC) Count of ≥ 12,000 cells / μL, if collected). Another medical condition, which, in the opinion of the PI (or authorized designee), may cause him / her to be non-compliant with the CIP, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of clinical investigation procedures and follow-up. Current participation in an investigational drug or device clinical investigation that has not completed the clinical investigation treatment or that clinically interferes with the clinical investigation endpoints. Note: Investigations requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational. Central venous stenosis or central vein narrowing ≥ 50% based on imaging, or any degree of central venous stenosis with accompanying signs or symptoms, on the same side as the planned AVF creation. The absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via DUS or angiography. Occlusion or stenosis ≥ 50%, or any degree of stenosis with accompanying signs or symptoms of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via DUS or angiography and as clinically determined by PI (or authorized designee). Significantly compromised venous or arterial architecture (e.g. severe vessel calcification) or flow in the treatment arm as determined by the PI (or authorized designee) and DUS or angiography. Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the PI (or authorized designee).

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: WavelinQ™ EndoAVF System<br>The WavelinQ™ EndoAVF System is indicated for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an AVF used for HD. The device is intended to be used in patients suffering from chronic kidney disease requiring HD by physicians trained and experienced in endovascular techniques. The WavelinQ™ EndoAVF System will be used for these intended purposes as part of this clinical investigation according to its instructions for use (IFU). | Device: WavelinQ™ EndoAVF System<br>* AVF endovascular creations using the WavelinQ™ EndoAVF System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Device and Procedure Related Serious Adverse Events (SAEs) | The proportion of participants with freedom from Clinical Events Committee (CEC) adjudicated device- or procedure-related SAEs. | 30 days | 
| Effectiveness: Number of Post Creation Interventions | The number of interventions post creation to facilitate and / or maintain AVF use (facilitation interventions and / or maintenance interventions). | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device and Procedure Related SAEs | The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs. | 6- and 24-months | 
| Physiological Maturation | The proportion of participants with AVFs that meet the clinical investigation plan (CIP) definition of physiological maturation as measured by duplex ultrasound (DUS). | 6-weeks | 
| Cannulation Success | The interval of time between HD arteriovenous (AV) access creation to first successful use for HD and proportion of participants with successful first use for HD as defined in the CIP. | 6-months | 
| Cumulative Functional Patency | The time from first successful HD AV access use for HD using 2-needle cannulation to access abandonment, when the access reaches an access censoring event as specified a priori in the CIP, or analysis timepoint / clinical investigation end. | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Replacement Therapy, Hemodialysis, Vascular Access, Arteriovenous Access, Arteriovenous Fistula, Endovascular Arteriovenous Fistula