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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390037
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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Brief Summary:
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

Condition or disease
Aneurysm

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Study Start Date : March 2015
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : November 4, 2016
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of major stroke or neurological death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Device related neurologic adverse event rate [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neuroradiologists and surgeons practice
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390037


Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Germany
Alfried Krupp Krankenhaus
Essen, Germany
Uniklinik Koln
Koln, Germany
Greece
Hellenic Air Force Hospital
Athens, Greece
Italy
IRCCS Fondazione Istituto Neurologico C Besta
Milan, Italy
Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Edoardo Boccardi, M.D. Ospedale Niguarda "Ca' Granda"
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02390037    
Other Study ID Numbers: NV PED 09
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases