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everlinQ Endovascular Access System Enhancements (EASE) Study

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ClinicalTrials.gov Identifier: NCT03708770
Recruitment Status : Completed
First Posted : October 17, 2018
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
TVA Medical Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Device: everlinQ endoAVF System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: everlinQ Endovascular Access System Enhancements (EASE) Study
Actual Study Start Date : July 27, 2015
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : June 19, 2017

Arm Intervention/treatment
endoAVF Device: everlinQ endoAVF System



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Number of Days to Fistula Maturation [ Time Frame: Days from Index Procedure ]
    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).

  2. Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure [ Time Frame: 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.

  3. Primary Patency at 6 Months Post-index Procedure [ Time Frame: 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.

  4. Number of Participants Per Catheter Exposure Type [ Time Frame: 1-7 days, 30 days, 3, and 6 months post-index procedure ]
    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.

  5. Number of Participants With Technical Success [ Time Frame: 1-7 days following index-procedure ]
    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.

  6. Number of Endo-AVF-related Re-interventions [ Time Frame: At 6 months follow-up ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Study Documents (Full-Text)

Documents provided by TVA Medical Inc.:

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Responsible Party: TVA Medical Inc.
ClinicalTrials.gov Identifier: NCT03708770     History of Changes
Other Study ID Numbers: CD-0015
First Posted: October 17, 2018    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency