Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Tab Title Description
Describes 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.
- Jacksonville, Florida: 16-006704
NCT ID: NCT02729740
Sponsor Protocol Number: CLP 10023.B
About this study
The primary objective of this study is to gather post market data on the Penumbra SMART Coil™ System in the treatment of intracranial aneurysms and other malformations.
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.
Patients enrolled in this study must sign Informed Consent and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Life expectancy less than one year
- Smart, PC 400, or POD account for less than 75% of total number of coils opened
- Participation in another clinical investigation that could confound the evaluation of the study device
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
Mayo Clinic principal investigator
Rabih Tawk, M.D.
Closed for enrollment
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available