Prospective Study on Embolization of Intracranial Aneurysms with Pipeline™ Embolization Device
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-004896
NCT ID: NCT02186561
Sponsor Protocol Number: NV-PED-07
About this study
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
- Age 22-80 years.
- Subject has a target intracranial aneurysm (IA) located in the anterior or posterior circulation.
- Subject has a target IA with a wide aneurysm neck.
Exclusion Criteria:
- Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
- Major surgery in the last 30 days.
- History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
- Any known contraindication to treatment with the Pipeline™ device.
- Pregnant women.
- Participating in another clinical trial.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator David Kallmes, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available