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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Kidney Diseases
Intervention Device: everlinQ endoAVF System
Enrollment 32
Recruitment Details First subject enrolled July 27, 2015 and last subject enrolled November 8, 2016. Last subject follow-up was June 19, 2017.
Pre-assignment Details  
Arm/Group Title endoAVF
Hide Arm/Group Description everlinQ arteriovenous fistula (endoAVF) System
Period Title: Overall Study
Started 32
Completed 22
Not Completed 10
Arm/Group Title endoAVF
Hide Arm/Group Description everlinQ endoAVF System
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age of Participants Number Analyzed 32 participants
50.9  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
1
   3.1%
Male
31
  96.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Hispanic or Latino
32
 100.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Paraguay Number Analyzed 32 participants
32
Fistula Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Ulnar-Ulnar
12
  37.5%
Radial-Radial
20
  62.5%
Access Arm  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Right
7
  21.9%
Left
25
  78.1%
Access Artery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Radial
19
  59.4%
Brachial
9
  28.1%
Ulnar
4
  12.5%
Access Vein  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Radial
17
  53.1%
Brachial
13
  40.6%
Ulnar
2
   6.3%
1.Primary Outcome
Title Number of Participants With Protocol-Defined endoAVF Maturation
Hide Description 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.
Time Frame Through 6 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
29
  90.6%
2.Primary Outcome
Title Number of Participants With Device-Related SAEs
Hide Description The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.
Time Frame 3 months following AVF creation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Number of Days to Fistula Maturation
Hide Description 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).
Time Frame Days from Index Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Days from Index Procedure
9.2  (19.1)
4.Secondary Outcome
Title Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure
Hide Description Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment.
Time Frame 6 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Percentage of participants
86.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection endoAVF
Comments

This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.

The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis.

Type of Statistical Test Other
Comments No power calculation was performed for this study.
Other Statistical Analysis The Secondary Patency rate was determined via Kaplan-Meier methods.
5.Secondary Outcome
Title Primary Patency at 6 Months Post-index Procedure
Hide Description 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.
Time Frame 6 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Percentage of participants
83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection endoAVF
Comments

This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.

The Primary Patency endpoint was calculated using a Kaplan-Meier analysis.

Type of Statistical Test Other
Comments No power calculation was performed for this study.
Other Statistical Analysis The primary patency rate was determined via Kaplan-Meier methods.
6.Secondary Outcome
Title Number of Participants Per Catheter Exposure Type
Hide Description 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.
Time Frame 1-7 days, 30 days, 3, and 6 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants (n) for each follow-up period varies from total participants in the study (N=32) according to the number of participants that attend follow-up and/or had data relevant to the analysis.
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
CVC only at 1-7 days post index procedure Number Analyzed 32 participants
31
  96.9%
EndoAVF only at 1-7 days post index procedure Number Analyzed 32 participants
0
   0.0%
CVC & endoAVF at 1-7 days post index procedure Number Analyzed 32 participants
0
   0.0%
No dialysis at 1-7 days post-index procedure Number Analyzed 32 participants
1
   3.1%
CVC only at 30 days post-index procedure Number Analyzed 28 participants
26
  92.9%
EndoAVF only at 30 days post-index procedure Number Analyzed 28 participants
1
   3.6%
CVC & endoAVF at 30 days post-index procedure Number Analyzed 28 participants
0
   0.0%
No dialysis at 30 days post-index procedure Number Analyzed 28 participants
1
   3.6%
CVC only at 3 months post-index Number Analyzed 16 participants
5
  31.3%
EndoAVF only 3 months post-index Number Analyzed 16 participants
10
  62.5%
CVC + endoAVF at 3 months post-index Number Analyzed 16 participants
0
   0.0%
No dialysis at 3 months post-index Number Analyzed 16 participants
1
   6.3%
CVC only at 6 months post-index Number Analyzed 26 participants
7
  26.9%
EndoAVF only 6 months post-index Number Analyzed 26 participants
19
  73.1%
CVC + endoAVF at 6 months post-index Number Analyzed 26 participants
0
   0.0%
No dialysis at 6 months post-index Number Analyzed 26 participants
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Technical Success
Hide Description 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.
Time Frame 1-7 days following index-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
30
  93.8%
8.Secondary Outcome
Title Number of Endo-AVF-related Re-interventions
Hide Description 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.
Time Frame At 6 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title endoAVF
Hide Arm/Group Description:
everlinQ arteriovenous fistula (endoAVF) System
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.3%
Time Frame Serious Adverse Events (SAEs) were collected through 6-months post-index procedure.
Adverse Event Reporting Description

Significant Adverse Events are defined as device or procedure-related adverse events (AE) that either, a) could be limb-threatening if not promptly identified or treated, or b) required additional therapy to reestablish patency of the endoAVF access circuit; irrespective of whether the event was an SAE. The SAE table combines both Significant Events and SAE events.

Only AEs relevant to index-procedure, study device, access site or endoAVF were collected and are included in the Other AE table.

 
Arm/Group Title endoAVF
Hide Arm/Group Description everlinQ arteriovenous fistula (endoAVF) System
All-Cause Mortality
endoAVF
Affected / at Risk (%)
Total   5/32 (15.63%)    
Show Serious Adverse Events Hide Serious Adverse Events
endoAVF
Affected / at Risk (%) # Events
Total   2/32 (6.25%)    
Blood and lymphatic system disorders   
Bleeding/Hematoma  [1]  1/32 (3.13%)  1
Cardiac disorders   
Heart problems  [2]  1/32 (3.13%)  1
Indicates events were collected by systematic assessment
[1]
Procedure related.
[2]
Not device or procedure-related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
endoAVF
Affected / at Risk (%) # Events
Total   7/32 (21.88%)    
Blood and lymphatic system disorders   
Bleeding/Hematoma   2/32 (6.25%)  2
Vascular disorders   
Occlusion/Thrombosis   4/32 (12.50%)  4
Occlusion/Stenosis   1/32 (3.13%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Courtney Rothwell
Organization: Becton Dickinson (BPV)
Phone: 480.350.6037
EMail: courtney.rothwell@bd.com
Layout table for additonal information
Responsible Party: TVA Medical Inc.
ClinicalTrials.gov Identifier: NCT03708770     History of Changes
Other Study ID Numbers: CD-0015
First Submitted: July 26, 2018
First Posted: October 17, 2018
Results First Submitted: April 30, 2019
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019