A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System

Completed

• Conditions: Intracranial Aneurysms
• Interventions: Device: PC 400 coils

• Registration Number: NCT01754051
• Lead Sponsor: Penumbra Inc.

Brief Summary

This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-21
• Study Start: 2013-01
• Primary Completion: 2017-10-03
• Study Completion: 2017-10-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients older than 18 years
• Intracranial aneurysms >2mm, ruptured or unruptured

Exclusion Criteria

• Fusiform aneurysms
• Dissecting aneurysms
• Aneurysms associated with brain AVMs
• Multiple aneurysms
• Re-treated aneurysms
• Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment by the PC 400 coils	PC 400 coils	Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use.

Primary Outcome Measures

Name	Time	Method
Time of fluoroscopic exposure	During the procedure
Packing density with the number of coils implanted	During the procedure
Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale	At 1 year post-procedure
Procedural device-related serious adverse events at immediate post-procedure	During the procedure

Secondary Outcome Measures

Name	Time	Method
Adverse events occurring during the procedure and in the 30±7 days following the treatment.	During and at 30 days post-procedure
Acute occlusion of the aneurysm sac at immediate post-procedure	At immediate post-procedure

Trial Locations

Locations (1)

CHU Pellegrin; 🇫🇷 Bordeaux, France