Study of the Penumbra Coil 400 System to Treat Aneurysm

Intracranial Aneurysms Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465841
• Other study ID #: CLP 4492
• Secondary ID: CLP 4492
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: June 2017

Study information

• Verified date: June 2020
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms
• Peripheral Aneurysms

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	Fort Sanders Medical Center	Knoxville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	Hoag Hospital	Newport Beach	California
United States	State University of New York Upstate Medical Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Intracranial Hemorrhage		At discharge or 3 days post-procedure