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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc. Identifier:
First received: December 17, 2012
Last updated: September 26, 2016
Last verified: September 2016
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 Intervention
Intracranial Aneurysms Device: PC 400 coils

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System in France

Resource links provided by NLM:

Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment by the PC 400 coils Device: PC 400 coils


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01754051

Contact: Rosio Barraza, MS 510 748 3200
Contact: Siu Po Sit, PhD 510748 3200 ext 221

Hôpital Côte de Nacre Recruiting
Caen Cedex 9, France
Contact: Prof. Patrick Courthéoux, MD         
Principal Investigator: Prof. Patrick Courthéoux, MD         
CHU Reims - Hôpital Maison Blanche Recruiting
Reims Cedex, France
Contact: Prof. Laurent Pierot, MD         
Principal Investigator: Prof. Laurent Pierot, MD         
Sponsors and Collaborators
Penumbra Inc.
Principal Investigator: Prof. Laurent Pierot, MD CHU Reims - Hôpital Maison Blanche
  More Information

Responsible Party: Penumbra Inc. Identifier: NCT01754051     History of Changes
Other Study ID Numbers: CLP 4818
CLP 4818 ( Other Identifier: Penumbra Inc )
Study First Received: December 17, 2012
Last Updated: September 26, 2016

Additional relevant MeSH terms:
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 19, 2017