Back to resultseverlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
everlinQ endoAVF System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
- Eligible for a native arteriovenous fistula.
- Adult (age >18 years old).
- Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
- Target vein diameter(s) at fistula site ≥ 2.0 mm.
- Target artery diameter at fistula site ≥ 2.0 mm.
- Procedural access site artery and vein diameter ≥ 2.0 mm.
- At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
- Estimated life expectancy > 1 year.
- Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.
- Presence of an antecubital perforating vein diameter ≥ 2.0 mm.
Exclusion Criteria:
- Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation.
- Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by the everlinQ System as deemed by the interventionalists' clinical judgment.
- Prior surgically created access in the planned treatment location.
- Functioning surgical access in the planned treatment arm.
- Pregnant women.
- New York Heart Association (NYHA) class III or IV heart failure.
- Hypercoagulable state.
- Known bleeding diathesis.
- Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
- 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.
- Currently being treated with another investigational device or drug.
- 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.
- Patients who do not have an ulnar or radial artery.
- Distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula.
- Evidence of calcification in vessels at the fistula site.
- Evidence of active infections on the day of the index procedure.
- Written informed consent not obtained.
Sites / Locations
- Sanatorio Italiano
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
endoAVF
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Procedural Success
Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
Adverse Event Rate
Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).
Secondary Outcome Measures
Percentage of Participants With Primary Patency at 6 Months Post Index Procedure
Primary Patency was defined as the time interval between the endoAVF index procedure and the earlier of a) any intervention designed to maintain or reestablish patency, b) access thrombosis, or c) access abandonment. Kaplan-Meier (KM) was used to analyze the data.
Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure
Maturity of the endoAVF was defined by duplex ultrasound criteria, as described in the literature as a useful surrogate of suitability for dialysis. Maturation was defined as duplex ultrasound flow in the brachial artery of at least 500 ml/min and a vein diameter ≥ 4mm, without significant stenosis or thrombosis. If a subject was on hemodialysis, maturity was defined by successful dialysis with 2-needles at least once.
Time to Cannulation (Months)
The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.
Number of Participants With Cannulation Success at Defined Follow-up Intervals
A subject was referred to as a 'cannulation success' with the first successful 2-needle cannulation of the endoAVF access circuit. "Cannulation Success" was defined by at least one successful hemodialysis session through a 2-needle cannulation of the endoAVF access circuit. "Cumulative Cannulation Success" = (Successes Through End Current Interval) / (Subjects on Dialysis at Start Current Interval + Censored Dialysis Subjects through End of Last Interval).
Percentage of Participants With Assisted Primary Patency at 6 Months
Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.
Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure
Secondary Patency was defined as the time interval between the endoAVF index procedure and a) access abandonment, or b) loss to thrombosis, irrespective of intervening surgical or endovascular interventions designed to re-establish functionality in a stenosed or thrombosed access circuit.
Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure
The interval of time from the first 2-needle dialysis utilizing the access until access abandonment (SVS Reporting Standards definition). Functional Patency was the interval of time from the first 2-needle dialysis of the endoAVF access circuit until access abandonment.
Number of Participants With EndoAVF Related Reintervention
The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post index procedure.
Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure
Modified Primary Patency was defined as a measure of patency that, in addition to occlusion or reinterventions within the access circuit, also included coil embolization or open surgical ligation of outflow venous branches as failures of patency when they occur after the index procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03708562
Brief Title
everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Official Title
everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVA Medical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.
Detailed Description
A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects may be followed for up to 12 months post index procedure based on Investigator's discretion. The duration of the study is expected to be approximately two (2) years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endoAVF
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
everlinQ endoAVF System
Intervention Description
The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
Primary Outcome Measure Information:
Title
Number of Participants With Procedural Success
Description
Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
Time Frame
At time of procedure
Title
Adverse Event Rate
Description
Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).
Time Frame
3 months following endoAVF creation
Secondary Outcome Measure Information:
Title
Percentage of Participants With Primary Patency at 6 Months Post Index Procedure
Description
Primary Patency was defined as the time interval between the endoAVF index procedure and the earlier of a) any intervention designed to maintain or reestablish patency, b) access thrombosis, or c) access abandonment. Kaplan-Meier (KM) was used to analyze the data.
Time Frame
6 months post index procedure
Title
Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure
Description
Maturity of the endoAVF was defined by duplex ultrasound criteria, as described in the literature as a useful surrogate of suitability for dialysis. Maturation was defined as duplex ultrasound flow in the brachial artery of at least 500 ml/min and a vein diameter ≥ 4mm, without significant stenosis or thrombosis. If a subject was on hemodialysis, maturity was defined by successful dialysis with 2-needles at least once.
Time Frame
1, 3, and 6 months post index procedure
Title
Time to Cannulation (Months)
Description
The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.
Time Frame
Months from index procedure to cannulation
Title
Number of Participants With Cannulation Success at Defined Follow-up Intervals
Description
A subject was referred to as a 'cannulation success' with the first successful 2-needle cannulation of the endoAVF access circuit. "Cannulation Success" was defined by at least one successful hemodialysis session through a 2-needle cannulation of the endoAVF access circuit. "Cumulative Cannulation Success" = (Successes Through End Current Interval) / (Subjects on Dialysis at Start Current Interval + Censored Dialysis Subjects through End of Last Interval).
Time Frame
0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure
Title
Percentage of Participants With Assisted Primary Patency at 6 Months
Description
Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.
Time Frame
6 months post index procedure
Title
Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure
Description
Secondary Patency was defined as the time interval between the endoAVF index procedure and a) access abandonment, or b) loss to thrombosis, irrespective of intervening surgical or endovascular interventions designed to re-establish functionality in a stenosed or thrombosed access circuit.
Time Frame
6 months post index procedure
Title
Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure
Description
The interval of time from the first 2-needle dialysis utilizing the access until access abandonment (SVS Reporting Standards definition). Functional Patency was the interval of time from the first 2-needle dialysis of the endoAVF access circuit until access abandonment.
Time Frame
6 months post index procedure
Title
Number of Participants With EndoAVF Related Reintervention
Description
The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post index procedure.
Time Frame
At 6 months follow-up
Title
Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure
Description
Modified Primary Patency was defined as a measure of patency that, in addition to occlusion or reinterventions within the access circuit, also included coil embolization or open surgical ligation of outflow venous branches as failures of patency when they occur after the index procedure.
Time Frame
6 months post index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible for a native arteriovenous fistula.
Adult (age >18 years old).
Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
Target vein diameter(s) at fistula site ≥ 2.0 mm.
Target artery diameter at fistula site ≥ 2.0 mm.
Procedural access site artery and vein diameter ≥ 2.0 mm.
At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
Estimated life expectancy > 1 year.
Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.
Presence of an antecubital perforating vein diameter ≥ 2.0 mm.
Exclusion Criteria:
Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation.
Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by the everlinQ System as deemed by the interventionalists' clinical judgment.
Prior surgically created access in the planned treatment location.
Functioning surgical access in the planned treatment arm.
Pregnant women.
New York Heart Association (NYHA) class III or IV heart failure.
Hypercoagulable state.
Known bleeding diathesis.
Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
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.
Currently being treated with another investigational device or drug.
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.
Patients who do not have an ulnar or radial artery.
Distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula.
Evidence of calcification in vessels at the fistula site.
Evidence of active infections on the day of the index procedure.
Written informed consent not obtained.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Ebner
Organizational Affiliation
Sanatorio Italiano, Paraguay
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanatorio Italiano
City
Asunción
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
We'll reach out to this number within 24 hrs