Study of the Penumbra Coil 400 System to Treat Aneurysm

Study Overview
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Brief Summary
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This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.

Official Title
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ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System

Conditions
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Intracranial Aneurysms, Peripheral Aneurysms

Intervention / Treatment
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* Device: PC 400 coils (Penumbra )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of: Intracranial aneurysms Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae Arterial and venous embolizations in the peripheral vasculature Exclusion Criteria: Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization with the PC 400 coils<br> | Device: PC 400 coils (Penumbra )<br>* The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Packing Density With the Number of Coils Implanted | The data will be captured at the end of the coiling procedure which is standard for aneurysm studies. | At immediate post-procedure | 
| Time of Fluoroscopic Exposure | The total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coiling procedure. | At immediate post-procedure | 
| Procedural Device-related Serious Adverse Events | Procedural on-the-table serious adverse events will be captured and recorded at the end of the procedure. The duration of the procedure can be variable, depending on the time to access the target lesion and the time to complete the coiling procedure. | At immediate post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Occlusion of the Aneurysm Sac | Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome. | At immediate post-procedure | 
| Intracranial Hemorrhage |  | At discharge or 3 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial aneurysms, Peripheral aneurysms, acute treatment, PC 400 System, packing density