Back to resultseverlinQ Endovascular Access System Enhancements (EASE) Study
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
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) ≥ 2.0 mm or large enough to accommodate device diameter.
- Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter.
- 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
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 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. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16
- Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
- Patients who do not have an ulnar or radial artery.
- At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula.
- Evidence of active infections on the day of the index procedure.
- Written informed consent not obtained.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
endoAVF
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Protocol-Defined endoAVF Maturation
Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles.
Number of Participants With Device-Related SAEs
The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.
Secondary Outcome Measures
Number of Days to Fistula Maturation
Defined as the number of days between the date of AVF creation and the date of endoAVF maturation (based on primary efficacy endpoint definition of maturation).
Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure
Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment.
Primary Patency at 6 Months Post-index Procedure
Primary Patency is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site to maintain or reestablish patency or loss of endoAVF patency. The primary patency rate is determined via Kaplan-Meier methods and based on the time of endoAVF creation until any intervention designed to maintain or reestablish patnecy or endoAVF abandonment.
Number of Participants Per Catheter Exposure Type
Number of participants with Central Venous Catheters (CVC), endoAVF only access, CVC + endoAVF access, and not reciving dialysis at 3 and 6 months post-index procedure.
Number of Participants With Technical Success
Technical success is defined as verification that an endoAVF has been created and remains patent 1-7 days after the index procedure. Patency is determined by experienced examiner as the presence of a bruit that is detected with stethoscope, or presence of thrill, or via Duplex Ultrasound, or via angiogram.
Number of Endo-AVF-related Re-interventions
The re-intervention rate for endo-AVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post-index procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03708770
Brief Title
everlinQ Endovascular Access System Enhancements (EASE) Study
Official Title
everlinQ Endovascular Access System Enhancements (EASE) Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2015 (Actual)
Primary Completion Date
June 19, 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVA Medical Inc.
4. Oversight
5. Study Description
Brief Summary
Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.
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 will be followed for up to 12 months post index procedure based on Investigator's discretion.
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
32 (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
Number of Participants With Protocol-Defined endoAVF Maturation
Description
Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles.
Time Frame
Through 6 months post-index procedure
Title
Number of Participants With Device-Related SAEs
Description
The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.
Time Frame
3 months following AVF creation
Secondary Outcome Measure Information:
Title
Number of Days to Fistula Maturation
Description
Defined as the number of days between the date of AVF creation and the date of endoAVF maturation (based on primary efficacy endpoint definition of maturation).
Time Frame
Days from Index Procedure
Title
Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure
Description
Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment.
Time Frame
6 months post-index procedure
Title
Primary Patency at 6 Months Post-index Procedure
Description
Primary Patency is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site to maintain or reestablish patency or loss of endoAVF patency. The primary patency rate is determined via Kaplan-Meier methods and based on the time of endoAVF creation until any intervention designed to maintain or reestablish patnecy or endoAVF abandonment.
Time Frame
6 months post-index procedure
Title
Number of Participants Per Catheter Exposure Type
Description
Number of participants with Central Venous Catheters (CVC), endoAVF only access, CVC + endoAVF access, and not reciving dialysis at 3 and 6 months post-index procedure.
Time Frame
1-7 days, 30 days, 3, and 6 months post-index procedure
Title
Number of Participants With Technical Success
Description
Technical success is defined as verification that an endoAVF has been created and remains patent 1-7 days after the index procedure. Patency is determined by experienced examiner as the presence of a bruit that is detected with stethoscope, or presence of thrill, or via Duplex Ultrasound, or via angiogram.
Time Frame
1-7 days following index-procedure
Title
Number of Endo-AVF-related Re-interventions
Description
The re-intervention rate for endo-AVF (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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 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) ≥ 2.0 mm or large enough to accommodate device diameter.
Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter.
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
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 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. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16
Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
Patients who do not have an ulnar or radial artery.
At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula.
Evidence of active infections on the day of the index procedure.
Written informed consent not obtained.
12. IPD Sharing Statement
Learn more about this trial
everlinQ Endovascular Access System Enhancements (EASE) Study
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