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

Penumbra

Status: Completed

Conditions: Intracranial Aneurysms

Treatments: Device: PC 400 coils

Study type: Observational

Funder types: Industry

Identifiers

NCT01754051

CLP 4818 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Treatment by the PC 400 coils

Description:

Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use.

Treatment:

Device: PC 400 coils