MANTA Registry for Vascular Large-bore Closure
- Conditions
- Femoral Arteriotomy Closure
- Registration Number
- NCT03330002
- Lead Sponsor
- Essential Medical, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (9)
St Paul's Hospital
🇨🇦Vancouver, Canada
Vancouver General Health
🇨🇦Vancouver, Canada
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Helsinki University Hospital
🇫🇮Helsinki, Finland
University of Turku
🇫🇮Turku, Finland
OLVG
🇳🇱Amsterdam, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
St Paul's Hospital🇨🇦Vancouver, Canada