Study of the Penumbra Coil 400 System to Treat Aneurysm

Not Applicable

Completed

• Conditions: Peripheral Aneurysms; Intracranial Aneurysms
• Interventions: Device: PC 400 coils (Penumbra )

• Registration Number: NCT01465841
• Lead Sponsor: Penumbra Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-28
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-06
• Results First Submitted: 2020-06-01
• Results First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Results First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolization with the PC 400 coils	PC 400 coils (Penumbra )	-

Primary Outcome Measures

Name	Time	Method
Packing Density With the Number of Coils Implanted	At immediate post-procedure	The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.
Time of Fluoroscopic Exposure	At immediate post-procedure	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.
Procedural Device-related Serious Adverse Events	At immediate post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Acute Occlusion of the Aneurysm Sac	At immediate post-procedure	Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome.
Intracranial Hemorrhage	At discharge or 3 days post-procedure

Trial Locations

Locations (6)

State University of New York Upstate Medical Center; 🇺🇸 Syracuse, New York, United States

Hoag Hospital; 🇺🇸 Newport Beach, California, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Fort Sanders Medical Center; 🇺🇸 Knoxville, Tennessee, United States

The Methodist Hospital Research Institute; 🇺🇸 Houston, Texas, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States