Trial Outcomes & Findings for Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device (NCT NCT02521948)
NCT ID: NCT02521948
Last Updated: 2018-10-29
Results Overview
Composite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring blood transfusion or vascular repair * Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm) * Femoral artery stenosis at the access site requiring intervention * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair * Permanent access site-related nerve injury (lasting\>30 days)
COMPLETED
NA
50 participants
Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure
2018-10-29
Participant Flow
Participant milestones
| Measure |
MANTA Vascular Closure Device (Total)
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
MANTA Vascular Closure Device (Total)
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Did not attend one or both follow-ups
|
6
|
Baseline Characteristics
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
Baseline characteristics by cohort
| Measure |
MANTA Vascular Closure Device (Total)
n=50 Participants
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
|---|---|
|
Age, Continuous
|
79.5 years
STANDARD_DEVIATION 8.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedureComposite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring blood transfusion or vascular repair * Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm) * Femoral artery stenosis at the access site requiring intervention * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair * Permanent access site-related nerve injury (lasting\>30 days)
Outcome measures
| Measure |
MANTA Vascular Closure Device (Total)
n=50 Participants
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
14F MANTA Device
14F subgroup of MANTA device
|
18F MANTA Device
18F subgroup of MANTA device
|
|---|---|---|---|
|
Number of Participants With Major Complications
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the first 10 minutes of cutting the MANTA sutureHemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)
Outcome measures
| Measure |
MANTA Vascular Closure Device (Total)
n=50 Participants
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
14F MANTA Device
n=16 Participants
14F subgroup of MANTA device
|
18F MANTA Device
n=34 Participants
18F subgroup of MANTA device
|
|---|---|---|---|
|
Hemostasis Success
|
47 Participants
|
16 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
Outcome measures
| Measure |
MANTA Vascular Closure Device (Total)
n=50 Participants
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
14F MANTA Device
14F subgroup of MANTA device
|
18F MANTA Device
18F subgroup of MANTA device
|
|---|---|---|---|
|
Time to Hemostasis
|
2.38 minutes
Standard Deviation 6.63
|
—
|
—
|
Adverse Events
MANTA Vascular Closure Device (Total)
Device Related Adverse Events
Serious adverse events
| Measure |
MANTA Vascular Closure Device (Total)
n=50 participants at risk
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
Device Related Adverse Events
n=50 participants at risk
Device related adverse events for the overall population
|
|---|---|---|
|
Vascular disorders
Excessive access site bleeding
|
4.0%
2/50 • 60 days
|
4.0%
2/50 • 60 days
|
|
Vascular disorders
Pseudoaneurysm
|
2.0%
1/50 • 60 days
|
2.0%
1/50 • 60 days
|
|
Vascular disorders
Bleeding/hemorrhage
|
4.0%
2/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Infections and infestations
Infection
|
6.0%
3/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Cardiac disorders
Other
|
30.0%
15/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Nervous system disorders
Minor Stroke
|
2.0%
1/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Vascular disorders
Cerebrovascular Attack
|
2.0%
1/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Gastrointestinal disorders
Other
|
4.0%
2/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Renal and urinary disorders
Other
|
2.0%
1/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
4.0%
2/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Other
|
2.0%
1/50 • 60 days
|
0.00%
0/50 • 60 days
|
Other adverse events
| Measure |
MANTA Vascular Closure Device (Total)
n=50 participants at risk
The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
|
Device Related Adverse Events
n=50 participants at risk
Device related adverse events for the overall population
|
|---|---|---|
|
Vascular disorders
Excessive access site bleeding
|
6.0%
3/50 • 60 days
|
6.0%
3/50 • 60 days
|
|
Vascular disorders
Hematoma >6cm
|
20.0%
10/50 • 60 days
|
20.0%
10/50 • 60 days
|
|
Vascular disorders
Hematoma <= 6cm
|
38.0%
19/50 • 60 days
|
38.0%
19/50 • 60 days
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/50 • 60 days
|
0.00%
0/50 • 60 days
|
|
Vascular disorders
Femoral artery stenosis at access site
|
34.0%
17/50 • 60 days
|
34.0%
17/50 • 60 days
|
|
Cardiac disorders
Other
|
60.0%
30/50 • 60 days
|
0.00%
0/50 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place