PC400 Coils for Treatment of Intracranial Aneurysms

Intracranial Aneurysms, Saccular Aneurysm

Intracranial aneurysm, Coiling

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.

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 traditional 0.010-inch coils. This design also reduces procedure and fluoroscopy times, improving overall efficiency. Several retrospective reports have highlighted its advantages in packing density, procedure time, and cost-effectiveness.1,2,3 However, there is a lack of high-level prospective data to support these findings. The goal of the present study is to determine occlusion rates and safety when Penumbra PC400 coils are used in the treatment of ruptured or unruptured medium and large sized (5mm or more) intracranial aneurysms. Up to 100 patients ≥ 18 and ≤ 80 years presenting with ruptured or unruptured saccular aneurysms who meet all eligibility criteria will be enrolled. Enrolled subjects must be treated with Penumbra PC400 coils used in any combination comprising a minimum of 80% total coil length used. The primary safety endpoint is procedure- or disease-related death or major stroke within 30 days of treatment or major ipsilateral stroke, neurological death or rebleeding from the target aneurysm during the 18-month follow-up period. The primary efficacy endpoint is Adequate angiographic occlusion at 18 ± 6 months without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm. This will be assessed by an imaging core lab using digital subtraction angiograms (DSA). Secondary endpoints include Clinical outcome (mRS) at 30 days, clinical outcome (mRS) at 18 months, packing density as measured by volumetric filling of the aneurysm immediately post-procedure, mean number of coils, procedural duration (in minutes), retreatment rate due to recurrence at 18 months, adequate angiographic occlusion at 18 without rebleed of the target aneurysm, occlusion stability at 18 months, peri-/post-procedural adverse events related to the device and/or the procedure. Data will be shared with the coordinating center, Semmes Murphey Foundation, via a secure electronic database, REDCap. Access to the REDCap database will only be granted to IRB approved research personnel from participating sites. Subjects will be given a subject ID in the database. Throughout the data collection period, investigators may maintain a linking key that links the subject to their ID. This linking key will only be accessible to the investigator and site personnel. Once data collection has been completed, the linking key will be erased so that there will be no way to re-link subjects with their research data. Research data from each site will only be accessible to the approved research personnel at that site; authorized research personnel from the coordinating center will only have access to the coded data in the REDCap database for each site for study monitoring purposes. No patient contact will occur outside of standard of care procedures. Participating sites will execute a Data Use Agreement (DUA) with the coordinating center.

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United States