N/A
N=500
MANTA Registry for Vascular Large-bore Closure
Femoral Arteriotomy Closure
Bottom Line
View on ClinicalTrials.gov: NCT03330002 ↗Enrolled (actual)
500
Serious AEs
22.0%
Results posted
May 2021
Primary outcome: Primary: Time to Hemostasis — 50 seconds
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CE-marked MANTA vascular closure device (VCD) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Essential Medical, Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis |
50 | — |
| PRIMARY Number of Participants With One or More Major Access Site Related Complications |
20 | — |
| SECONDARY Number of Participants With One or More Minor Access Site Related Complications |
29 | — |
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.
Eligibility Criteria
Per MANTA VCD Instructions for Use (IFU)
Data sourced from ClinicalTrials.gov (NCT03330002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.