Trial Outcomes & Findings for Artegraft Versus Propaten Dialysis Grafts (NCT NCT02099344)
NCT ID: NCT02099344
Last Updated: 2019-05-15
Results Overview
The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
12 months
Results posted on
2019-05-15
Participant Flow
Participant milestones
| Measure |
Propaten
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access
|
Artegraft
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Propaten
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access
|
Artegraft
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Artegraft Versus Propaten Dialysis Grafts
Baseline characteristics by cohort
| Measure |
Propaten
n=1 Participants
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access
|
Artegraft
Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.
Artegraft: Surgical placement of graft for hemodialysis access
Propaten: Surgical placement of graft for hemodialysis access
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
—
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data not collected due to early study termination
The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not collected due to early study termination
Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.
Outcome measures
Outcome data not reported
Adverse Events
Propaten
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Artegraft
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