Trial Outcomes & Findings for BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial (NCT NCT04146012)
NCT ID: NCT04146012
Last Updated: 2023-06-29
Results Overview
Early access success, defined by three cannulations, the first one started within 72 hours after implantation, all with minimum dialysis flow rates of 250 ml/min pump flow rate, with a minimum 17-gauge needle.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
less than 72 hours
Results posted on
2023-06-29
Participant Flow
Study terminated (Sale of Company) First patient implanted 3 Dec 2019 Last Patient implanted 16 Dec 2019
Participant milestones
| Measure |
Early Access
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Normal Access
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
17
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
30
|
15
|
Reasons for withdrawal
| Measure |
Early Access
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Normal Access
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
|---|---|---|
|
Overall Study
Study Terminated
|
30
|
15
|
Baseline Characteristics
BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
Baseline characteristics by cohort
| Measure |
Early Access
n=3 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Normal Access
n=2 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: less than 72 hoursPopulation: No statistical analysis of data was conducted.
Early access success, defined by three cannulations, the first one started within 72 hours after implantation, all with minimum dialysis flow rates of 250 ml/min pump flow rate, with a minimum 17-gauge needle.
Outcome measures
| Measure |
Early Access
n=3 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Normal Access
n=2 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
|---|---|---|
|
Number of Participants That Were Successfully Cannulated.
|
3 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Less than 6 monthPopulation: No statistical analysis of data was conducted.
A composite of major adverse clinical events (MACE) including perigraft infection, hemorrhage / hematoma, thrombosis, and pseudoaneurysm within 30 days after first cannulation \[Day 0\] in the early-access and late-access groups.
Outcome measures
| Measure |
Early Access
n=3 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Normal Access
n=2 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
|---|---|---|
|
Patients That Experienced Major Adverse Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Less than 6 monthsPopulation: No statistical analysis of data was conducted..
Patency (Primary, Assisted Primary, and Secondary) at 30 days after first successful cannulation \[Day 0\], and at 12 and 6 months after implantation in the early-access group and at 30 days post-Day 0 in the late-access group. The late access group will also be assessed for patency at 6 months through a telephone interview or office visit to provide a more robust data set.
Outcome measures
| Measure |
Early Access
n=3 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Normal Access
n=2 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
|---|---|---|
|
Grafts That Were Patent After 30 Days
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Less than 6 monthsPopulation: No statistical analysis of data was conducted.
All adverse events will be collected in the early-access group \[to 6 months\] and the late-access group \[to 30 days post Day 0\] and summarized by unique event, seriousness, and relationship to device or procedure.
Outcome measures
| Measure |
Early Access
n=3 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
Normal Access
n=2 Participants
Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.
Artegraft® Collagen Vascular Graft™ (Artegraft): The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
|
|---|---|---|
|
Patients That Experience Major Adverse Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Less than 6 monthsPopulation: Data was not collected
The number of days from graft implant or fistula revision to catheter removal shall be recorded.
Outcome measures
Outcome data not reported
Adverse Events
Early Access
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Access
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
Tony Calandra, President
Accidentals Inc. (Formally Artegraft Inc.)
Phone: 973.540.1250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place