N/A
N=32
everlinQ Endovascular Access System Enhancements (EASE) Study
Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03708770 ↗Enrolled (actual)
32
Serious AEs
6.3%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Protocol-Defined endoAVF Maturation — 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- everlinQ endoAVF System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Protocol-Defined endoAVF Maturation |
29 | — |
| PRIMARY Number of Participants With Device-Related SAEs |
— | — |
| SECONDARY Number of Days to Fistula Maturation |
9.2 | — |
| SECONDARY Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure |
86.8 | — |
| SECONDARY Primary Patency at 6 Months Post-index Procedure |
83.3 | — |
| SECONDARY Number of Participants Per Catheter Exposure Type |
31; 0; 0; 1; 26; 1 | — |
| SECONDARY Number of Participants With Technical Success |
30 | — |
| SECONDARY Number of Endo-AVF-related Re-interventions |
2 | — |
Summary
Prospective, single-center study to evaluate the everlinQ System when used to create an endoAVF in hemodialysis patients.
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.
- "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.
Data sourced from ClinicalTrials.gov (NCT03708770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.