Femoral Arteriotomy Closure
Conditions
Keywords
Arterial Closure Device, Large Bore Closure Device
Brief summary
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
Interventions
DEVICECE-marked MANTA vascular closure device (VCD)
Compile real word data on MANTA VCD.
Sponsors
Essential Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
Per MANTA VCD Instructions for Use (IFU)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | Immediately after deployment of MANTA VCD | 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). |
| Number of Participants With One or More Major Access Site Related Complications | within 30 days of procedure | Major access site related complications adapted from the VARC-2 definitions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Minor Access Site Related Complications | within 30 days of procedure | Minor access site related complications adapted from the VARC-2 definitions |
Countries
Canada, Denmark, Finland, Netherlands, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MANTA Vascular Closure Device (VCD) MANTA VCD following percutaneous cardiac or peripheral procedures (TAVI, MCS, EVAR, TEVAR) for large bore (10-18F ID) interventional devices. | 500 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 15 |
Baseline characteristics
| Characteristic | MANTA Vascular Closure Device (VCD) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 491 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Age, Continuous | 80.8 years STANDARD_DEVIATION 6.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 71 participants | — |
| Region of Enrollment Denmark | 29 participants | — |
| Region of Enrollment Finland | 96 participants | — |
| Region of Enrollment Netherlands | 277 participants | — |
| Region of Enrollment Switzerland | 27 participants | — |
| Sex: Female, Male Female | 226 Participants | — |
| Sex: Female, Male Male | 274 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 500 |
| other Total, other adverse events | 98 / 500 |
| serious Total, serious adverse events | 110 / 500 |
Outcome results
Primary
Number of Participants With One or More Major Access Site Related Complications
Major access site related complications adapted from the VARC-2 definitions
Time frame: within 30 days of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANTA Vascular Closure Device (VCD) | Number of Participants With One or More Major Access Site Related Complications | 20 Participants |
Primary
Time to Hemostasis
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).
Time frame: Immediately after deployment of MANTA VCD
Population: Time to Hemostasis (TTH) was captured in 491/500 subject; 9 subjects did not have TTH recorded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MANTA Vascular Closure Device (VCD) | Time to Hemostasis | 50 seconds |
Secondary
Number of Participants With One or More Minor Access Site Related Complications
Minor access site related complications adapted from the VARC-2 definitions
Time frame: within 30 days of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANTA Vascular Closure Device (VCD) | Number of Participants With One or More Minor Access Site Related Complications | 29 Participants |