Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Essential Medical, Inc.
- Enrollment
- 500
- Locations
- 9
- Primary Endpoint
- Number of Participants With One or More Major Access Site Related Complications
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With One or More Major Access Site Related Complications
Time Frame: within 30 days of procedure
Major access site related complications adapted from the VARC-2 definitions
Time to Hemostasis
Time Frame: 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).
Secondary Outcomes
- Number of Participants With One or More Minor Access Site Related Complications(within 30 days of procedure)