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

C. R. Bard21 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Kidney Disease Chronic Kidney Diseases Kidney Failure Kidney Insufficiency

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: The participant must: 1. 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). 2. Be able to and willing to comply with the CIP requirements, including clinical follow-up. 3. 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. 4. 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. 5. Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or angiography. 6. A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography. 7. Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or authorized designee). 8. 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: 1. Active or nontreated hypercoagulable state. 2. Known bleeding diathesis. 3. Insufficient cardiac output to support the maturation and use of an AVF in the opinion of the PI (or authorized designee). 4. Known history of or current active intravenous drug abuse. 5. 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. 6. Known allergy or hypersensitivity to contrast media which cannot be adequately treated with pre-medication. 7. Known adverse effects to sedation and / or anesthesia which cannot be adequately treated with pre-medication. 8. 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). 9. 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. 10. 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. 11. 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. 12. The absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via DUS or angiography. 13. 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). 14. 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. 15. 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).

Outcomes

Primary Outcomes

Safety: Device and Procedure Related Serious Adverse Events (SAEs) - Presented as the Number of Participants With Freedom From Clinical Events Committee (CEC) Adjudicated Device and/or Procedure-Related SAEs.

Clinical Investigation Plan (CIP) Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs. The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events. NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs.

Time frame: 30 days

Effectiveness: Number of Interventions Per Patient Years to Facilitate and / or Maintain AVF Use

CIP Endpoint Definition: The number of interventions per patient years to facilitate and / or maintain AVF use (facilitation interventions and / or maintenance interventions). The assessment of interventions to facilitate and/or maintain AVF use started post creation (after the completion of the index procedure). NOTE: For the calculation of the endpoint, the number of Interventions per Patient Years to Facilitate and / or Maintain AVF Use was to be estimated by using the Poisson regression model. Given the early termination of the investigation the mean and standard deviation of the Number of Interventions and Patient Years used for the derivation are provided in the Analysis Population Description.

Time frame: 6 months

Secondary Outcomes

Device and Procedure Related SAEs - Presented as the Number of Participants With Freedom From CEC Adjudicated Device and/or Procedure-Related SAEs.

CIP Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs. The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events. NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs. This included the assessment of the 12 participants that reached 6-months prior to investigation early termination. No further related SAEs were identified in this time period from the one part of the primary safety endpoint.

Time frame: 6 months (24 months was also to be reported per the CIP but due to investigation early termination only data through 6 months was able to be evaluated).

Physiological Maturation - Presented as the Number of Participants With AVFs That Meet the CIP Definition of Physiological Maturation as Measured by Duplex Ultrasound (DUS).

CIP Endpoint Definition: The proportion of participants with AVFs that meet the CIP definition of physiological maturation as measured by DUS. Core Lab data was the primary source for endpoint derivation. In the event where core lab data was unavailable, site reported data was used. Physiological maturation was defined as an AVF having at least 500 mL/min of flow in the brachial artery and an outflow vein diameter of ≥4 mm as measured by DUS. Participants with AVFs that met the definition of functional maturation were automatically considered to have met the endpoint of physiological maturation. NOTE: Due to the early termination of the investigation this endpoint is presented as the number of participants with AVFs that meet the definition of physiological maturation as measured by DUS.

Time frame: 6 weeks

Cannulation Success - Presented as the Percentage of Participants With Cannulation Success.

Time frame: 6 months

Cannulation Success - Presented as the Number of Days to Cannulation Success.

CIP Endpoint Definition: 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. Cannulation Success is defined as the first successful use for HD using 2-needle cannulation. The median time to success was to be estimated using the Kaplan Meier curve and defined as the time at which 50% of participants reached success by the end of the 6-month window. By the end of the 6-month window, the estimated success rate was 46.2% (see Secondary Outcome above "Cannulation Success - Percentage of Participants With Cannulation Success") as such, there weren't sufficient data points with successes to get this estimate. Instead the minimum and maximum number of days to cannulation success for all participants through investigation early termination is provided.

Time frame: Through Investigation Early Termination

Cumulative Functional Patency - Presented as the Number of Participants With Cumulative Functional Patency

CIP Endpoint Definition: 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. NOTE: Given the early termination of the investigation the endpoint is presented as the number of participants that had met the definition of cumulative functional patency - those that (1) had initiated HD successfully through their AVF with 2-needle cannulation and (2) whose AVF was not abandoned.

Time frame: 6 months (12 months per CIP but due to investigation early termination data is reported through 6 months instead due to the limited resultant data available at 12 months)