NCT03708770CompletedNot Applicable
everlinQ Endovascular Access System Enhancements (EASE) Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- C. R. Bard
- Enrollment
- 32
- Primary Endpoint
- Number of Participants With Device-Related SAEs
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •"Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment.
- •Currently being treated with another investigational device or drug.
- •Known allergy to contrast dye which cannot be adequately pre-medicated. CD-0015 Rev 02 - EASE Study Clinical Protocol CONFIDENTIAL Page 8 of 16
- •Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
- •Patients who do not have an ulnar or radial artery.
- •At the time of procedure distance between target artery and vein will not allow magnets to align vessels sufficiently to create the fistula.
- •Evidence of active infections on the day of the index procedure.
- •Written informed consent not obtained.
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)
Investigators
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