Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

Study Overview
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Brief Summary
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The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.

Detailed Description
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This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.

Official Title
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SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Penumbra Smart Coil
* Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients enrolled in this study must sign the Informed Consent Form 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 Exclusion Criteria: Life expectancy less than one year Smart, PC 400, or POD account for less than 75% of total number of coils implanted Participation in another clinical investigation that could confound the evaluation of the registry device
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 |
| --- | --- |
| Other: Penumbra Smart System<br> | Device: Penumbra Smart Coil<br> <br> Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)<br>* Other Penumbra Coils available as standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving Adequate Occlusion Immediate Post Procedure | Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure. | Immediate Post Procedure | 
| Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout | Re-access attempts due to catheter kick-out across all coils | Immediate Post Procedure | 
| Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure |  | Immediate Post Procedure | 
| Number of Participants Requiring Retreatment Through Follow-up |  | One year from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penumbra Smart coils, PC 400, AV malformations, AV fistulae, POD