Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Completed
- Conditions
- Aneurysm
- Registration Number
- NCT02390037
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- 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™.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of major stroke or neurological death 1 year
- Secondary Outcome Measures
Name Time Method Device related neurologic adverse event rate 1 year
Trial Locations
- Locations (7)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
Alfried Krupp Krankenhaus
🇩🇪Essen, Germany
Uniklinik Koln
🇩🇪Koln, Germany
Hellenic Air Force Hospital
🇬🇷Athens, Greece
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, United Kingdom
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
IRCCS Fondazione Istituto Neurologico C Besta
🇮🇹Milan, Italy