Clinical trial NCT03708770: everlinQ Endovascular Access System Enhancements (EASE) Study
Official title: everlinQ Endovascular Access System Enhancements (EASE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: TVA Medical Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Eligible for a native arteriovenous fistula.
2. Adult (age \>18 years old).
3. Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
4. Target vein diameter(s) ≥ 2.0 mm or large enough to accommodate device diameter.
5. Target artery diameter ≥ 2.0 mm or large enough to accommodate device diameter.
6. Estimated life expectancy \> 1 year.
7. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure

Exclusion Criteria:

1. Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation.
2. 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.
3. Prior surgically created access in the planned treatment location.
4. Functioning surgical access in the planned treatment arm.
5. Pregnant women.
6. New York Heart Association (NYHA) class III or IV heart failure.
7. Hypercoagulable state.
8. Known bleeding diathesis.
9. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
10. Documented history of drug abuse including intravenous drugs within six months of AVF creation.
11. "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment.
12. Currently being treated with another investigational device or drug.
13. Known allergy to contrast dye which cannot be adequately pre-medicated. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16
14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
15. Patients who do not have an ulnar or radial artery.
16. At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula.
17. Evidence of active infections on the day of the index procedure.
18. Written informed consent not obtained.

Primary outcomes:
measure: Number of Participants With Protocol-Defined endoAVF Maturation
timeFrame: Through 6 months post-index procedure
measure: Number of Participants With Device-Related SAEs
timeFrame: 3 months following AVF creation
Secondary outcomes:
measure: Number of Days to Fistula Maturation
timeFrame: Days from Index Procedure
measure: Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure
timeFrame: 6 months post-index procedure
measure: Primary Patency at 6 Months Post-index Procedure
timeFrame: 6 months post-index procedure
measure: Number of Participants Per Catheter Exposure Type
timeFrame: 1-7 days, 30 days, 3, and 6 months post-index procedure
measure: Number of Participants With Technical Success
timeFrame: 1-7 days following index-procedure
measure: Number of Endo-AVF-related Re-interventions
timeFrame: At 6 months follow-up
Other outcomes:
Locations:
Study officials:
References: