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OpenTrials
Completed

NCT Number: NCT03330002

MANTA Registry for Vascular Large-bore Closure

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.

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Key information

Conditions

Femoral Arteriotomy Closure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Paul's Hospital, Vancouver, Canada

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Per MANTA VCD Instructions for Use (IFU)

Treatment and study plan

CE-marked MANTA vascular closure device (VCD)

Device

Compile real word data on MANTA VCD.

Primary outcomes

  1. Time to Hemostasis

    Time frame: Immediately after deployment of MANTA VCD

    The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).

  2. Number of Participants With One or More Major Access Site Related Complications

    Time frame: within 30 days of procedure

    Major access site related complications adapted from the VARC-2 definitions

Secondary outcomes

  1. Number of Participants With One or More Minor Access Site Related Complications

    Time frame: within 30 days of procedure

    Minor access site related complications adapted from the VARC-2 definitions

Sponsors and collaborators

Lead sponsor

Essential Medical, Inc.

Industry

Registry information

Official study title

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)

Acronym: MARVEL

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Nov 6, 2017
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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