MANTA Registry for Vascular Large-bore Closure (MARVEL)

April 12, 2021 updated by: Essential Medical, Inc.

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Vancouver, Canada
        • St Paul's Hospital
      • Vancouver, Canada
        • Vancouver General Health
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Turku, Finland
        • University of Turku
  • Netherlands
      • Amsterdam, Netherlands
        • OLVG
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus Medical Center
  • Switzerland
      • Luzern, Switzerland
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.

Description

Per MANTA VCD Instructions for Use (IFU)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CE-marked MANTA vascular closure devices per IFU
Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc.
Device: CE-marked MANTA vascular closure device (VCD)
Compile real word data on MANTA VCD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately after deployment of MANTA VCD
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
within 30 days of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 30 days of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essential Medical, Inc.

Investigators

  • Principal Investigator: Nicolas Van Mieghem, MD, Erasmus Medical Center Rotterdam Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Actual)

August 8, 2019

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSD-212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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