NCT01465841

Study of the Penumbra Coil 400 System to Treat Aneurysm

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 517 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intracranial Aneurysms
• Peripheral Aneurysms

Interventions

Type	Name	Description
DEVICE	PC 400 coils (Penumbra )	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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2011-11-07
• Last updated: 2020-07-07
• Results posted: 2020-07-07

Locations

6 sites across 1 country: United States