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

Primary Purpose

End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WavelinQ™ EndoAVF System
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Kidney Disease focused on measuring Kidney Replacement Therapy, Hemodialysis, Vascular Access, Arteriovenous Access, Arteriovenous Fistula, Endovascular Arteriovenous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Imelda Hospital Bonheiden
  • University Hospital of Patras "Panagia I Voitheia"
  • Kantonsspital Winterthur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WavelinQ™ EndoAVF System

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Device and Procedure Related SAEs
The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs.
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).
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.
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.

Full Information

First Posted
November 10, 2020
Last Updated
June 15, 2022
Sponsor
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT04626427
Brief Title
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
Acronym
WAVE-Global
Official Title
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to shifting post-pandemic clinical landscape, concurrent study (NCT04634916) to provide results on analogous endpoints in advance of current projections
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WavelinQ™ EndoAVF System
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
WavelinQ™ EndoAVF System
Intervention Description
AVF endovascular creations using the WavelinQ™ EndoAVF System
Primary Outcome Measure Information:
Title
Safety: Device and Procedure Related Serious Adverse Events (SAEs)
Description
The proportion of participants with freedom from Clinical Events Committee (CEC) adjudicated device- or procedure-related SAEs.
Time Frame
30 days
Title
Effectiveness: Number of Post Creation Interventions
Description
The number of interventions post creation to facilitate and / or maintain AVF use (facilitation interventions and / or maintenance interventions).
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Device and Procedure Related SAEs
Description
The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs.
Time Frame
6- and 24-months
Title
Physiological Maturation
Description
The proportion of participants with AVFs that meet the clinical investigation plan (CIP) definition of physiological maturation as measured by duplex ultrasound (DUS).
Time Frame
6-weeks
Title
Cannulation Success
Description
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.
Time Frame
6-months
Title
Cumulative Functional Patency
Description
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.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charmaine Lok, MD, MSc
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicholas Inston, PhD
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panagiotis Kitrou, MD, MSc, PhD
Organizational Affiliation
University Hospital of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital Bonheiden
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
University Hospital of Patras "Panagia I Voitheia"
City
Río
ZIP/Postal Code
26504
Country
Greece
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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