This trial is active, not recruiting.

Condition aneurysm
Phase phase 4
Sponsor Medtronic Neurovascular Clinical Affairs
Start date March 2015
End date December 2016
Trial size 50 participants
Trial identifier NCT02390037, NV PED 09


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Occurrence of major stroke or neurological death
time frame: 1 year

Secondary Outcomes

Device related neurologic adverse event rate
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Principal investigator Edoardo Boccardi, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Medtronic Neurovascular Clinical Affairs.