Penumbra PC400 Coils for Treatment of Medium and Large Sized (5mm or More) Intracranial Aneurysms: A Prospective Multicenter Study
Semmes-Murphey Foundation
Summary
The goal of this prospective, observational study is to evaluate the long-term occlusion rates and safety of the Penumbra PC400 coil in the treatment of ruptured and unruptured intracranial aneurysms in adult subjects ages 18-80. Specifically, the study aims to analyze rate of death, stroke, neurological death, or rebleeding associated with the treatment of intracranial aneurysm with the PC400 coil. Participants will undergo standard of care treatment and follow up for their aneurysm treatment, and participating sites will collect procedural and follow up data.
Description
Endovascular treatment has become the primary approach for intracranial aneurysms, offering improved safety and reduced recanalization rates. Despite advancements in flow diversion and intrasaccular devices, coiling remains a cornerstone therapy. However, aneurysmal recurrence due to regrowth or coil compaction continues to be a significant concern, with recurrence observed in about 20% of cases, leading to potential rebleeding and treatment challenges. The Penumbra PC400 coil (Penumbra Inc., Alameda, CA, USA) addresses these concerns by offering 400% more volume per unit length than traditio…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject is ≥ 18 and ≤ 80 years of age. * Subject has a previously untreated, ruptured or unruptured, saccular intracranial aneurysm 5mm or more in diameter for which the clinical decision to treat with Penumbra PC400 embolization coils has been made independent of the decision to enroll the subject in the study described in this protocol. * The decision to undergo the coiling procedure is made independently of and prior to participation in the research. * Subject has a baseline Hunt and Hess Score of I, II, or III. * Subject must be considered by the treating physician t…
Location
- Semmes Murphey ClinicMemphis, Tennessee