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TerminatedNCT04626427WAVE-GlobalUpdated Jan 16, 2025Results posted

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

An interventional study of WavelinQ™ EndoAVF System in End Stage Kidney Disease, Chronic Kidney Diseases and Kidney Failure, sponsored by C. R. Bard. Terminated at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by C. R. Bard · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to shifting post-pandemic clinical landscape, concurrent study (NCT04634916) to provide results on analogous endpoints in advance of current projections
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

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

Keywords

  • Kidney Replacement Therapy
  • Hemodialysis
  • Vascular Access
  • Arteriovenous Access
  • Arteriovenous Fistula
  • Endovascular Arteriovenous Fistula
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 21 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

C. R. Bard is the lead sponsor of 113 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    WavelinQ™ EndoAVF System

    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

Interventions

  • DeviceWavelinQ™ EndoAVF System

    AVF endovascular creations using the WavelinQ™ EndoAVF System

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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).

  2. 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

  3. Cannulation Success - Presented as the Percentage of Participants With 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. NOTE: Given the early termination of the investigation, this endpoint is presented as the percentage of participants with successful first use for HD. The Kaplan-Meier (KM) method was used to estimate the proportion of participants with success at 6 months.

    Time frame: 6 months

  4. 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

  5. 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)

07

Results

Posted Jan 16, 2025
Limitations and caveats
Early termination leading to small number of participants analyzed. Given the limited sample size of the investigation population, the testing of the hypotheses described in the CIP was not completed for the primary endpoints and instead data are presented in a descriptive fashion.

Participant flow

21 participants signed informed consent prior to investigation early termination.

Participant flow — Overall Study
MilestoneWavelinQ™ EndoAVF System
Started14
30-day follow-up13
6-week follow-up12
3-month follow-up12
6-month follow-up11
12-month follow-up2
Completed0
Not completed14
Withdrew: Death1
Withdrew: Withdrawal by subject1
Withdrew: Investigation early termination by sponsor11
Withdrew: Participant permanently moved abroad1

Outcome measures

PrimarySafety: 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
Reported as:
Count of participants · Participants
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.
ParticipantsWavelinQ™ EndoAVF System
Overall Number of Participants with Freedom from CEC Adjudicated Device &/ Procedure Related SAEs12
Possible Procedure-Related SAE (Azotaemia - 7 days Post-Index Procedure with 4 Day Hospitalization)1
PrimaryEffectiveness: 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
Reported as:
Number · Number of Interventions / Patient Years
Effectiveness: Number of Interventions Per Patient Years to Facilitate and / or Maintain AVF Use
Number of Interventions / Patient YearsWavelinQ™ EndoAVF System
Effectiveness: Number of Interventions Per Patient Years to Facilitate and / or Maintain AVF Use1.00
SecondaryDevice 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).
Reported as:
Count of participants · Participants
Device and Procedure Related SAEs - Presented as the Number of Participants With Freedom From CEC Adjudicated Device and/or Procedure-Related SAEs.
ParticipantsWavelinQ™ EndoAVF System
Overall Number of Participants with Freedom from CEC Adjudicated Device &/ Procedure Related SAEs11
Possible Procedure-Related SAE (Azotaemia - 7 days Post-Index Procedure with 4 Day Hospitalization)1
SecondaryPhysiological 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
Reported as:
Count of participants · Participants
Physiological Maturation - Presented as the Number of Participants With AVFs That Meet the CIP Definition of Physiological Maturation as Measured by Duplex Ultrasound (DUS).
ParticipantsWavelinQ™ EndoAVF System
Overall Number of Participants with Physiological Maturation12
Missing DUS / HD Data - Unable to Confirm Physiological Maturation (CIP Deviation)1
SecondaryCannulation Success - Presented as the Percentage of Participants With 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. NOTE: Given the early termination of the investigation, this endpoint is presented as the percentage of participants with successful first use for HD. The Kaplan-Meier (KM) method was used to estimate the proportion of participants with success at 6 months.

Time frame:
6 months
Reported as:
Number · % of Participants with Success
Cannulation Success - Presented as the Percentage of Participants With Cannulation Success.
% of Participants with SuccessWavelinQ™ EndoAVF System
Percentage of All Participants with Success - KM (%)46.2
Percentage of HD Eligible Participants with Cannulation Success (%)72.7
SecondaryCannulation 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
Reported as:
Median · Time to Success (Days)
Cannulation Success - Presented as the Number of Days to Cannulation Success.
Time to Success (Days)WavelinQ™ EndoAVF System
Cannulation Success - Presented as the Number of Days to Cannulation Success.NA (32 to 210)
SecondaryCumulative 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)
Reported as:
Count of participants · Participants
Cumulative Functional Patency - Presented as the Number of Participants With Cumulative Functional Patency
ParticipantsWavelinQ™ EndoAVF System
Cumulative Functional Patency - Presented as the Number of Participants With Cumulative Functional Patency5

Adverse events

Collected over Per the CIP, Adverse Events (AEs) were to be collected for intent-to-treat (ITT) participants immediately following the start of the index procedure (defined to start at the time of the initial skin puncture to gain vessel access) for the entire follow-up period of 24 months. Given the early termination of the investigation, the time frame varied individually for each participant - the mean number of years of follow up (standard deviation) was 0.498 (0.2).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
WavelinQ™ EndoAVF System1/14 (7.1%)7/14 (50%)4/14 (28.6%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventWavelinQ™ EndoAVF System
Arteriovenous Fistula Site ComplicationInjury, poisoning and procedural complications1/14
Arteriovenous Fistula Site ComplicationInjury, poisoning and procedural complications1/14
Arteriovenous Fistula Site PseudoaneurysmInjury, poisoning and procedural complications1/14
Arteriovenous Fistula ThrombosisInjury, poisoning and procedural complications1/14
Arteriovenous Fistula Site ComplicationInjury, poisoning and procedural complications1/14
Neoplasm MalignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/14
Arteriovenous Fistula Site ComplicationInjury, poisoning and procedural complications1/14
AzotaemiaRenal and urinary disorders1/14
Arteriovenous Fistula Site ComplicationInjury, poisoning and procedural complications1/14
Arteriovenous Fistula Site ComplicationInjury, poisoning and procedural complications1/14
Most frequent other events
Most frequent other events
EventWavelinQ™ EndoAVF System
Puncture Site HaematomaGeneral disorders1/14
Covid-19Infections and infestations1/14
Limb FractureInjury, poisoning and procedural complications1/14
Catheter Site HaemorrhageGeneral disorders1/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)WavelinQ™ EndoAVF System
Mean60.9 ± 16.52
Sex: Female, Male
Sex: Female, Male(Participants)WavelinQ™ EndoAVF System
Female3
Male11
Race (NIH/OMB)
Race (NIH/OMB)(Participants)WavelinQ™ EndoAVF System
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White13
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)WavelinQ™ EndoAVF System
Greece5
Belgium5
Switzerland4
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)WavelinQ™ EndoAVF System
Mean24.91 ± 4.536
08

Study locations

3 sites
  • Imelda Hospital Bonheiden
    Bonheiden, 2820, Belgium
  • University Hospital of Patras "Panagia I Voitheia"
    Río, 26504, Greece
  • Kantonsspital Winterthur
    Winterthur, 8401, Switzerland
09

References and documents

Study documents

  • Study protocol · Sep 23, 2020
  • Statistical analysis plan · Jun 22, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04626427
Lead sponsor
C. R. Bard
Responsible party
Sponsor
First posted
Nov 12, 2020
Start date
Dec 23, 2020
Primary completion
Jun 15, 2022
Completion
Jun 15, 2022
Results posted
Jan 16, 2025
Last update
Jan 16, 2025

Study contacts

Charmaine Lok, MD, MSc
principal investigator · University Health Network, Toronto
Nicholas Inston, PhD
principal investigator · The Queen Elizabeth Hospital
Panagiotis Kitrou, MD, MSc, PhD
principal investigator · University Hospital of Patras

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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