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 Type
OBSERVATIONAL
Enrollment
500
Compile real word data on MANTA VCD.
St Paul's Hospital
Vancouver, Canada
Vancouver General Health
Vancouver, Canada
Aarhus University Hospital
Aarhus, Denmark
Helsinki University Hospital
Helsinki, Finland
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
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
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
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University of Turku
Turku, Finland
OLVG
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Luzerner Kantonsspital
Lucerne, Switzerland