Aneurysm
Conditions
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™.
Interventions
None listed
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of major stroke or neurological death | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Device related neurologic adverse event rate | 1 year |
Countries
Belgium, Germany, Greece, Italy, Spain, United Kingdom
Outcome results
None listed