everlinQ endoAVF Post Market Study
Primary Purpose
Chronic Kidney Disease
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
everlinQ endoAVF System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Adult (age >18 years old)
- Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation
- Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram
- Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram
- Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)
Exclusion Criteria:
- Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation
- Absence of perforator feeding the target cannulation vein(s) via Venogram
- Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
- Significantly compromised (≥50% stenosis) flow in the treatment arm
- Documented ejection fraction (EF) ≤35% in the last 6 months
- Pregnant women
- New York Heart Association (NYHA) class III or IV heart failure
- Hypercoagulable state
- Known bleeding diathesis
- Documented history of drug abuse including intravenous drugs within six months of AVF creation
- "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
- Known allergy to contrast dye which cannot be adequately pre-medicated
- Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
- Evidence of active infections on the day of the index procedure
- Estimated life expectancy < 1 year
- Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
- Patient with a target cannulation vein that is > 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula
- Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.
Sites / Locations
- Providence Health Care Society
- University Hospital Carl Gustav Carus
- Dominikus Hospital
- University of Frankfurt
- University of Leipzig
- University of Mannheim
- St. Franziskus-Hospital Münster
- Oxford University Hospitals - NHS Foundation Trust
- University Hospitals Birmingham
- St. George's University
- Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
endoAVF
Arm Description
Outcomes
Primary Outcome Measures
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02682420
Brief Title
everlinQ endoAVF Post Market Study
Official Title
everlinQ endoAVF Post Market Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Company acquisition
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVA Medical Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endoAVF
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
everlinQ endoAVF System
Primary Outcome Measure Information:
Title
Participants With Primary Patency of the endoAVF at 6 Months Post-Index Procedure
Description
Primary patency was defined in this study as "The interval from the time of access placement until any intervention designed to maintain or re-establish patency, access thrombosis, access abandonment, or the time of measurement of patency".
Time Frame
endoAVF creation through 6 months
Other Pre-specified Outcome Measures:
Title
Participants With Assisted Primary Patency of the endoAVF at 6 Months Post-Index Procedure
Description
Assisted Primary Patency was defined in this study as "The interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion".
Time Frame
endoAVF creation through 6 Months
Title
Participants With Secondary Patency of the endoAVF at 6 Months Post-Index Procedure
Description
Secondary Patency in this study was defined as "The interval from the time of access placement until access abandonment, loss to thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access".
Time Frame
endoAVF creation through 6 Months
Title
Participants With Functional Patency of the endoAVF at 6 Months Post-Index Procedure
Description
Functional Patency in this study was defined as "The interval of time from the first 2-needle dialysis utilizing the access until access abandonment".
Time Frame
endoAVF creation through 6 Months
Title
Number of Days Post-Index Procedure for Participants to Achieve Successful Cannulation of the endoAVF
Description
The time (number of days) from the index procedure (successful endoAVF creation) to the first use of the endoAVF. This endpoint is evaluated per participant rather than at specific time points.
Time Frame
endoAVF creation to cannulation
Title
Number of Participants With Procedural Success at the Index Procedure
Description
The successful creation of an endoAVF with blood flow confirmed intraoperatively by fistulography or by duplex ultrasound postoperatively. This outcome measure is assessed at the time of the endoAVF creation.
Time Frame
endoAVF creation
Title
Number of Participants With Interventions Occurring During the Index Procedure (Adjunctive Procedures)
Description
The endoAVF-related interventions include:
Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.
Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.
Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.
Any intervention to address any complications or adverse events of the access circuit.
This outcome measure is assessed at the time of the endoAVF creation.
Time Frame
endoAVF creation
Title
Number of Participants With Interventions Occurring After the Index Procedure (Reinterventions)
Description
The endoAVF-related interventions include:
Interventions to maintain or restore patency of the endoAVF, including endovascular and surgical procedures designed to address occlusive thrombosis (resulting in absence of thrill or bruit at endoAVF) and clinically significant occlusive stenosis at or near endoAVF site.
Interventions to support maturation of the arterialized vein segments, including endovascular procedures such as secondary coil embolization to facilitate flow into the target cannulation veins.
Interventions to support cannulation of the arterialized vein segments, including procedures such as a superficialization or elevation where the target cannulation vein is brought closer to the skin surface to enable cannulation, without the creation of a new AV fistula.
Any intervention to address any complications or adverse events of the access circuit.
Time Frame
endoAVF creation through 6 Months
Title
Participants in Which endoAVF Maturation Was Achieved
Description
Total time from successful endoAVF creation to one of the following:
Successful hemodialysis using 2 needle cannulation OR
Vascular access that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least a 4.0 mm vein diameter as measured via duplex ultrasound.
Note: 63 participants completed the 6-month visit. Participants who did not receive a duplex ultrasound and have not yet successfully dialyzed using 2 needle cannulation are not counted for this endpoint.
Time Frame
endoAVF creation through 6 months
Title
Number of Participants That Were Not on Dialysis at endoAVF Creation and Are Central Venous Catheter (CVC) Free at Indicated Time Points
Description
Number of participants that were not on dialysis at endoAVF creation and are central venous catheter (CVC) free at indicated time points.
Time Frame
endoAVF creation through 6 Months
Title
Number of Participants That Experienced Device-related Serious Adverse Events Through 6 Months Post-Index Procedure
Description
AE that:
led to death,
led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the everlinQ endoAVF System
Time Frame
endoAVF creation through 6 Months
Title
Number of Participants That Experienced Procedure-related Serious Adverse Events Through 6 Months Post-Index Procedure
Description
AE that:
led to death,
led to serious deterioration in the health of the patient, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
led to fetal distress, fetal death or a congenital abnormality or birth defect And has been determined by the CEC to be related to the index procedure
Time Frame
endoAVF creation through 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (age >18 years old)
Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation
Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram
Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram
Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)
Exclusion Criteria:
Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation
Absence of perforator feeding the target cannulation vein(s) via Venogram
Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
Significantly compromised (≥50% stenosis) flow in the treatment arm
Documented ejection fraction (EF) ≤35% in the last 6 months
Pregnant women
New York Heart Association (NYHA) class III or IV heart failure
Hypercoagulable state
Known bleeding diathesis
Documented history of drug abuse including intravenous drugs within six months of AVF creation
"Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
Known allergy to contrast dye which cannot be adequately pre-medicated
Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
Evidence of active infections on the day of the index procedure
Estimated life expectancy < 1 year
Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
Patient with a target cannulation vein that is > 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula
Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Inston, MD
Organizational Affiliation
University Hospitals Birmingham NHS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Schmitz-Rixen, MD
Organizational Affiliation
Univerisity of Frankfurt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Health Care Society
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
University Hospital Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
Dominikus Hospital
City
Düsseldorf
Country
Germany
Facility Name
University of Frankfurt
City
Frankfurt
Country
Germany
Facility Name
University of Leipzig
City
Leipzig
Country
Germany
Facility Name
University of Mannheim
City
Mannheim
Country
Germany
Facility Name
St. Franziskus-Hospital Münster
City
Münster
Country
Germany
Facility Name
Oxford University Hospitals - NHS Foundation Trust
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospitals Birmingham
City
Birmingham
Country
United Kingdom
Facility Name
St. George's University
City
London
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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everlinQ endoAVF Post Market Study
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