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

• Sponsor: Penumbra Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01754051
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 57
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysms	Device: PC 400 coils

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Oct 3, 2017
• Actual Study Completion Date: Oct 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Treatment by the 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.	Device: PC 400 coils

Outcome Measures

Primary Outcome Measures

1. Packing density with the number of coils implanted [During the procedure]

2. Time of fluoroscopic exposure [During the procedure]

3. Procedural device-related serious adverse events at immediate post-procedure [During the procedure]

4. Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale [At 1 year post-procedure]

Secondary Outcome Measures

1. Acute occlusion of the aneurysm sac at immediate post-procedure [At immediate post-procedure]

2. Adverse events occurring during the procedure and in the 30±7 days following the treatment. [During and at 30 days post-procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Pellegrin	Bordeaux		France

Sponsors and Collaborators

• Penumbra Inc.

Investigators

• Principal Investigator: Dr. Jérôme Berge, MD, CHU Pellegrin - Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Penumbra Inc.
• ClinicalTrials.gov Identifier: NCT01754051
• Other Study ID Numbers: CLP 4818; CLP 4818
• First Posted: Dec 21, 2012
• Last Update Posted: May 17, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

No Results Posted as of May 17, 2018