everlinQ Endovascular Access System Enhancements (EASE) Study

Chronic Kidney Diseases Clinical Trial

Official title:

everlinQ Endovascular Access System Enhancements (EASE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708770
• Other study ID #: CD-0015
• Status: Completed
• Phase: N/A
• Start date: July 27, 2015
• Est. completion date: June 19, 2017

Study information

• Verified date: July 2023
• Source: TVA Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• everlinQ endoAVF System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TVA Medical Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through 6 months post-index procedure
Primary	Number of Participants With Device-Related SAEs	The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.	3 months following AVF creation
Secondary	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).	Days from Index Procedure
Secondary	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.	6 months post-index procedure
Secondary	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.	6 months post-index procedure
Secondary	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.	1-7 days, 30 days, 3, and 6 months post-index procedure
Secondary	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.	1-7 days following index-procedure
Secondary	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.	At 6 months follow-up