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
TVA Medical Inc.
Information provided by (Responsible Party):
TVA Medical Inc.
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Device: everlinQ endoAVF System
Primary Outcome Measures :
- 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.
- 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 :
- 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).
- 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.
- 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.
- 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.
- 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.
- 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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