Medina Embolization Device In Neurovascular Aneurysm Study (MEDINA)

May 16, 2019 updated by: Medtronic Neurovascular Clinical Affairs

The MEDINA Study: Medina Embolization Device In Neurovascular Aneurysms Study - A Post Market Clinical Follow-up Study

A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

15

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

  • Austria
      • Salzburg, Austria, 5020
        • Universitätsklinikum Christian Doppler Klinik Salzburg
  • Italy
      • Milan, Italy, 20162
        • Azienda Ospedaliera Ospedale Niguarda Cà Granda
  • Spain
      • Madrid, Spain, 28040
        • Hospital Fundacion Jimenez Diaz

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Saccular intracranial aneurysm not previously treated.

Description

Inclusion Criteria:

  • Subject has provided written informed consent using the Ethics Committee-approved consent form and agrees to comply with protocol requirements
  • Subject is 18- 85 years old
  • Subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the Medina Embolization Device

Exclusion Criteria:

  • Aneurysm is partially thrombosed
  • Aneurysm has been previously treated with surgery or endovascular therapy
  • Subject has had major brain surgery including endovascular procedures within the past 30 days
  • Vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm
  • Subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation
  • The Investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC)
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Medtronic Neurovascular Clinical Affairs

Collaborators

Medtronic Bakken Research Center

Investigators

  • Study Chair: Patrick Brouwer, Dr, Karolinska University Hospital

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)

December 15, 2016

Primary Completion (ACTUAL)

October 22, 2018

Study Completion (ACTUAL)

October 22, 2018

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (ESTIMATE)

December 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV-MED-01

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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