everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Chronic Kidney Diseases Clinical Trial

Official title:

everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708562
• Other study ID #: CD-0038
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: December 12, 2018

Study information

• Verified date: April 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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) 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• everlinQ endoAVF System
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.

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
TVA Medical Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At time of procedure
Primary	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).	3 months following endoAVF creation
Secondary	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.	6 months post index procedure
Secondary	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.	1, 3, and 6 months post index procedure
Secondary	Time to Cannulation (Months)	The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.	Months from index procedure to cannulation
Secondary	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).	0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure
Secondary	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.	6 months post index procedure
Secondary	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.	6 months post index procedure
Secondary	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.	6 months post index procedure
Secondary	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.	At 6 months follow-up
Secondary	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.	6 months post index procedure