everlinQ Endovascular Access System Enhancements (EASE) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- C. R. Bard
- Enrollment
- 32
- Primary Endpoint
- Number of Participants With Device-Related SAEs
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Number of Participants With Device-Related SAEs
Time Frame: 3 months following AVF creation
The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.
Number of Participants With Protocol-Defined endoAVF Maturation
Time Frame: Through 6 months post-index procedure
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.
Secondary Outcomes
- Number of Days to Fistula Maturation(Days from Index Procedure)
- Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure(6 months post-index procedure)
- Number of Endo-AVF-related Re-interventions(At 6 months follow-up)
- Primary Patency at 6 Months Post-index Procedure(6 months post-index procedure)
- Number of Participants With Technical Success(1-7 days following index-procedure)
- Number of Participants Per Catheter Exposure Type(1-7 days, 30 days, 3, and 6 months post-index procedure)