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

• ClinicalTrials.gov Identifier: NCT01754051
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Last Update Posted: May 17, 2018
• Sponsor: Penumbra Inc.
• Information provided by (Responsible Party): Penumbra Inc.

Tracking Information

• First Submitted Date: December 17, 2012
• First Posted Date: December 21, 2012
• Last Update Posted Date: May 17, 2018
• Study Start Date: January 2013
• Actual Primary Completion Date: October 3, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 17, 2012)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 17, 2012)

• Acute occlusion of the aneurysm sac at immediate post-procedure [ Time Frame: At immediate post-procedure ]
• Adverse events occurring during the procedure and in the 30±7 days following the treatment. [ Time Frame: During and at 30 days post-procedure ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
• Official Title: VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
• 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 Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Up to 200 patients with intracranial aneurysms treated by the PC 400 System at up to 20 centers will be enrolled.
• Condition: Intracranial Aneurysms
• Intervention: Device: PC 400 coils

Study Groups/Cohorts

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.

Intervention: Device: PC 400 coils

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 14, 2018): 100
• Original Estimated Enrollment (submitted: December 17, 2012): 200
• Actual Study Completion Date: October 3, 2017
• Actual Primary Completion Date: October 3, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01754051
• Other Study ID Numbers: CLP 4818; CLP 4818 ( Other Identifier: Penumbra Inc )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Penumbra Inc.
• Study Sponsor: Penumbra Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Penumbra Inc.
• Verification Date: May 2018