Trial Outcomes & Findings for Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access (NCT NCT03300024)
NCT ID: NCT03300024
Last Updated: 2019-05-21
Results Overview
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
TERMINATED
NA
10 participants
One year after Graft Placement
2019-05-21
Participant Flow
Participant milestones
| Measure |
Expanded Polytetrafluoroethylene (ePTFE)
The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion.
Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t
|
Bovine Carotid Artery Graft
The bovine carotid artery (BCA) biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Expanded Polytetrafluoroethylene (ePTFE)
The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion.
Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t
|
Bovine Carotid Artery Graft
The bovine carotid artery (BCA) biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Expanded Polytetrafluoroethylene (ePTFE)
n=4 Participants
The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion.
Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t
|
Bovine Carotid Artery Graft
n=6 Participants
The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
|
Age, Continuous
|
63.5 years
n=4 Participants
|
67.2 years
n=6 Participants
|
65.7 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: One year after Graft PlacementPopulation: Data was not collected for this outcome measure
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One year after Graft PlacementPopulation: Data was not collected for this outcome measure
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One year after Graft PlacementPopulation: Data was not collected for this outcome measure
Secondary patency is defined as the interval from graft placement to graft failure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One year after Graft PlacementPopulation: Data was not collected for this outcome measure
Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two years after Graft PlacementPopulation: Data was not collected for this outcome measure
Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two years after Graft PlacementPopulation: Data was not collected for this outcome measure
Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two years after Graft PlacementPopulation: Data was not collected for this outcome measure
Secondary patency is defined as the interval from graft placement to graft failure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two years after Graft PlacementPopulation: Data was not collected for this outcome measure
Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 18 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 24 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 months after Graft PlacementPopulation: Data was not collected for this outcome measure
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 months after Graft PlacementPopulation: Data was not collected for this outcome measure
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 18 months after Graft PlacementPopulation: Data was not collected for this outcome measure
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 24 months after Graft PlacementPopulation: Data was not collected for this outcome measure
The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 18 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 24 months after Graft PlacementPopulation: Data was not collected for this outcome measure
Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 months after Graft PlacementPopulation: Data was not collected for this outcome measure
At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 months after Graft PlacementPopulation: Data was not collected for this outcome measure
At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 18 months after Graft PlacementPopulation: Data was not collected for this outcome measure
At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 24 months after Graft PlacementPopulation: Data was not collected for this outcome measure
At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
Outcome measures
Outcome data not reported
Adverse Events
Expanded Polytetrafluoroethylene (ePTFE)
Bovine Carotid Artery Graft
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