CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
MANTA Vascular Closure Devicedevice
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.

Search/NCT02521948
NCT02521948N/ACompleted
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Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

Essential Medical, Inc.·interventional·Posted Aug 13, 2015·Updated Oct 29, 2018

In Brief

A clinical study evaluating MANTA Vascular Closure Device for Femoral Arteriotomy Closure. Completed, enrolled 50 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemoral Arteriotomy Closure
CountriesItaly, Netherlands
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 13, 2015
Enrollment StartJul 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.9 years ago

Interventions

MANTA Vascular Closure Devicedevice

The MANTA device developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.