Study of the Penumbra Coil 400 System to Treat Aneurysm

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	12/6/2018
Start Date:	November 2011
End Date:	June 2017

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

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.

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.

We found this trial at

sites

State University of New York, Upstate Medical Center

Syracuse, New York 13210

from

Syracuse, NY