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Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

NCT02521948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-10-29

Study results available
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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.

Conditions

  • Femoral Arteriotomy Closure

Interventions

DEVICE

MANTA Vascular Closure Device

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.

Sponsors & Collaborators

  • Essential Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-02-29
Completion
2016-05-31

Countries

  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521948 on ClinicalTrials.gov