MANTA Registry for Vascular Large-bore Closure

NCT03330002 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-05-05

Study results available
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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

  • Femoral Arteriotomy Closure

Interventions

DEVICE

CE-marked MANTA vascular closure device (VCD)

Compile real word data on MANTA VCD.

Sponsors & Collaborators

  • Essential Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicolas Van Mieghem, MD · Erasmus Medical Center Rotterdam Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2019-08-08
Completion
2021-02-01
FDA Device
Yes

Countries

  • Canada
  • Denmark
  • Finland
  • Netherlands
  • Switzerland

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 NCT03330002 on ClinicalTrials.gov