Trial Outcomes & Findings for VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC (NCT NCT02685995)
NCT ID: NCT02685995
Last Updated: 2021-02-08
Results Overview
The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow \>300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
30, 60 and 90 days
Results posted on
2021-02-08
Participant Flow
Participant milestones
| Measure |
Palindrome TDC
TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
VectorFlow TDC
TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Palindrome TDC
TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
VectorFlow TDC
TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
|---|---|---|
|
Overall Study
Insertion of immediately puncturable graft.
|
1
|
1
|
Baseline Characteristics
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Baseline characteristics by cohort
| Measure |
Palindrome TDC
n=50 Participants
TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
VectorFlow TDC
n=50 Participants
TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=39 Participants
|
59 years
n=41 Participants
|
58 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
54 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
100 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
50 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
100 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 30, 60 and 90 daysThe primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow \>300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.
Outcome measures
| Measure |
Palindrome TDC
n=49 Participants
TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
VectorFlow TDC
n=49 Participants
TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.
|
|---|---|---|
|
Primary Patency - Intervention-free Interval (Measured in Weeks)
30 Days
|
89.1 percentage of primary patency
Standard Error 6.2
|
95.5 percentage of primary patency
Standard Error 3.3
|
|
Primary Patency - Intervention-free Interval (Measured in Weeks)
60 Days
|
79.4 percentage of primary patency
Standard Error 10.0
|
87.2 percentage of primary patency
Standard Error 7.3
|
|
Primary Patency - Intervention-free Interval (Measured in Weeks)
90 days
|
71.5 percentage of primary patency
Standard Error 12.6
|
80.6 percentage of primary patency
Standard Error 9.8
|
Adverse Events
Palindrome TDC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VectorFlow TDC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place