Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study (PFLEX)

January 31, 2019 updated by: Medtronic Neurovascular Clinical Affairs
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

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

  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
  • Germany
      • Essen, Germany
        • Alfried Krupp Krankenhaus
      • Koln, Germany
        • Uniklinik Köln
  • Greece
      • Athens, Greece
        • Hellenic Air Force Hospital
  • Italy
      • Milan, Italy
        • IRCCS Fondazione Istituto Neurologico C Besta
  • Spain
      • Valladolid, Spain
        • Hospital Clinico Universitario De Valladolid
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital Birmingham

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neuroradiologists and surgeons practice

Description

Inclusion Criteria:

  1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
  2. Age 18-80 years.
  3. Subject has already been selected for flow diversion therapy as the appropriate treatment.
  4. Subject has an unruptured target intracranial aneurysm (IA).
  5. Subject has a target IA located in the anterior or posterior circulation.

Exclusion Criteria:

  1. Major surgery in the past 30 days.
  2. Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use.
  3. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.

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
Occurrence of major stroke or neurological death
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Device related neurologic adverse event rate
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Medtronic Neurovascular Clinical Affairs

Investigators

  • Principal Investigator: Edoardo Boccardi, M.D., Ospedale Niguarda "Ca' Granda"

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

March 1, 2015

Primary Completion (Actual)

November 4, 2016

Study Completion (Actual)

November 4, 2016

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV PED 09

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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