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

Medtronic

Status: Completed

Conditions: Aneurysm

Study type: Observational

Funder types: Industry

Identifiers

NCT02390037

NV PED 09

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.