NCT02729740

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 995 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Penumbra Smart Coil
DEVICE	Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)	Other Penumbra Coils available as standard of care

Timeline

• Start date: 2016-06-03
• Primary completion: 2019-12-27
• Completion: 2019-12-27
• First posted: 2016-04-06
• Last updated: 2021-03-01
• Results posted: 2021-03-01

Locations

72 sites across 2 countries: United States, Canada