Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study (PFLEX)
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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
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Condition or disease |
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Aneurysm |
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 |
- Occurrence of major stroke or neurological death [ Time Frame: 1 year ]
- Device related neurologic adverse event rate [ Time Frame: 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
- Age 18-80 years.
- Subject has already been selected for flow diversion therapy as the appropriate treatment.
- Subject has an unruptured target intracranial aneurysm (IA).
- Subject has a target IA located in the anterior or posterior circulation.
Exclusion Criteria:
- Major surgery in the past 30 days.
- Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use.
- Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.

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
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 |
Principal Investigator: | Edoardo Boccardi, M.D. | Ospedale Niguarda "Ca' Granda" |
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 |
Aneurysm Vascular Diseases Cardiovascular Diseases |