Trials / Completed
CompletedNCT03330002
MANTA Registry for Vascular Large-bore Closure
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- Essential Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CE-marked MANTA vascular closure device (VCD) | Compile real word data on MANTA VCD. |
Timeline
- Start date
- 2018-02-23
- Primary completion
- 2019-08-08
- Completion
- 2021-02-01
- First posted
- 2017-11-06
- Last updated
- 2021-05-05
- Results posted
- 2021-05-05
Locations
9 sites across 5 countries: Canada, Denmark, Finland, Netherlands, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03330002. Inclusion in this directory is not an endorsement.