At a glance
ClinicalIndex Comparison RecordN/ACompleted· 500 enrolled
Drug / intervention
CE-marked MANTA vascular closure device (VCD)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
An observational study evaluating CE-marked MANTA vascular closure device (VCD) for Femoral Arteriotomy Closure. Completed, enrolled 500 participants across 9 sites in 5 countries.
Detailed 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 Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsFemoral Arteriotomy Closure
CountriesCanada, Denmark, Finland, Netherlands, Switzerland
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartFeb 2018
Primary CompletionAug 2019
Study CompletionFeb 2021
TodayJul 2026
First PostedNov 6, 2017
Enrollment StartFeb 23, 2018
Primary CompletionAug 8, 2019
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.7 years ago
Interventions
CE-marked MANTA vascular closure device (VCD)device
Compile real word data on MANTA VCD.