Trial Outcomes & Findings for Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae (NCT NCT01471041)

Last Updated: 2016-06-03

Results Overview

Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

54 participants

Primary outcome timeframe

3 months

Results posted on

2016-06-03

Participant milestones
Measure	Venous Window Needle Guide Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium
Overall Study STARTED	54
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	7

Withdrawal data not reported

Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae

Baseline characteristics by cohort
Measure	Venous Window Needle Guide n=54 Participants Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium
Age, Continuous	60 Years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants

Timeframe: 3 months

Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.

Outcome measures
Measure	Venous Window Needle Guide n=51 Participants Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis	49 participants

Timeframe: 6 months

Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide

Outcome measures
Measure	Venous Window Needle Guide n=54 Participants Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide	14 participants

Serious events: 8 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events
Measure	Venous Window Needle Guide n=54 participants at risk Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium
Blood and lymphatic system disorders Stenosis at VWING	5.6% 3/54 • Number of events 3 • 6 mths
Blood and lymphatic system disorders Cannulation pain resulting in VWING removal	3.7% 2/54 • Number of events 2 • 6 mths
Blood and lymphatic system disorders Inability to cannulate resulting in VWING removal	3.7% 2/54 • Number of events 2 • 6 mths
Blood and lymphatic system disorders Sepsis	1.9% 1/54 • Number of events 1 • 6 mths

Other adverse events
Measure	Venous Window Needle Guide n=54 participants at risk Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium
Blood and lymphatic system disorders Infiltration	24.1% 13/54 • Number of events 13 • 6 mths
Blood and lymphatic system disorders Unable to cannulate	14.8% 8/54 • Number of events 8 • 6 mths
Blood and lymphatic system disorders Stenosis	9.3% 5/54 • Number of events 5 • 6 mths
Infections and infestations Infection	9.3% 5/54 • Number of events 5 • 6 mths
Blood and lymphatic system disorders Thrombus	3.7% 2/54 • Number of events 2 • 6 mths
Blood and lymphatic system disorders Seroma	3.7% 2/54 • Number of events 2 • 6 mths
Blood and lymphatic system disorders Bruising	3.7% 2/54 • Number of events 2 • 6 mths
Blood and lymphatic system disorders Pain	5.6% 3/54 • Number of events 3 • 6 mths
Blood and lymphatic system disorders Possible dislodge VWING	1.9% 1/54 • Number of events 1 • 6 mths
Blood and lymphatic system disorders Edema	1.9% 1/54 • Number of events 1 • 6 mths
Blood and lymphatic system disorders Bleeding following cannulation	1.9% 1/54 • Number of events 1 • 6 mths
Blood and lymphatic system disorders Incision dehiscence	1.9% 1/54 • Number of events 1 • 6 mths

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