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

Intracranial Aneurysms Clinical Trial

— VOLCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754051
• Other study ID #: CLP 4818
• Secondary ID: CLP 4818
• Status: Completed
• Start date: January 2013
• Est. completion date: October 3, 2017

Study information

• Verified date: May 2018
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 3, 2017
• Est. primary completion date: October 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• PC 400 coils

Locations

Country	Name	City	State
France	CHU Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Packing density with the number of coils implanted		During the procedure
Primary	Time of fluoroscopic exposure		During the procedure
Primary	Procedural device-related serious adverse events at immediate post-procedure		During the procedure
Primary	Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale		At 1 year post-procedure
Secondary	Acute occlusion of the aneurysm sac at immediate post-procedure		At immediate post-procedure
Secondary	Adverse events occurring during the procedure and in the 30±7 days following the treatment.		During and at 30 days post-procedure