Clinical trial NCT03708562: everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Official title: everlinQ Endovascular Access Systems Enhancements (EASE-2) 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: 24
Sex: ALL
Minimum age (years): 18
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 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.

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) at fistula site ≥ 2.0 mm.
5. Target artery diameter at fistula site ≥ 2.0 mm.
6. Procedural access site artery and vein diameter ≥ 2.0 mm.
7. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
8. Estimated life expectancy \> 1 year.
9. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.
10. Presence of an antecubital perforating vein diameter ≥ 2.0 mm.

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 the 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.
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. 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.
17. Evidence of calcification in vessels at the fistula site.
18. Evidence of active infections on the day of the index procedure.
19. Written informed consent not obtained.

Primary outcomes:
measure: Number of Participants With Procedural Success
timeFrame: At time of procedure
measure: Adverse Event Rate
timeFrame: 3 months following endoAVF creation
Secondary outcomes:
measure: Percentage of Participants With Primary Patency at 6 Months Post Index Procedure
timeFrame: 6 months post index procedure
measure: Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure
timeFrame: 1, 3, and 6 months post index procedure
measure: Time to Cannulation (Months)
timeFrame: Months from index procedure to cannulation
measure: Number of Participants With Cannulation Success at Defined Follow-up Intervals
timeFrame: 0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure
measure: Percentage of Participants With Assisted Primary Patency at 6 Months
timeFrame: 6 months post index procedure
measure: Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure
timeFrame: 6 months post index procedure
measure: Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure
timeFrame: 6 months post index procedure
measure: Number of Participants With EndoAVF Related Reintervention
timeFrame: At 6 months follow-up
measure: Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure
timeFrame: 6 months post index procedure
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: Sanatorio Italiano, Paraguay
name: Adrian Ebner
role: PRINCIPAL_INVESTIGATOR
References: