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.
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:
Accepts Healthy Volunteers:
Neuroradiologists and surgeons practice
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.
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.