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 February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01754051
First received: December 17, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 ] [ Designated as safety issue: No ]
  • Time of fluoroscopic exposure [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
  • Procedural device-related serious adverse events at immediate post-procedure [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute occlusion of the aneurysm sac at immediate post-procedure [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: No ]
  • Adverse events occurring during the procedure and in the 30±7 days following the treatment. [ Time Frame: During and at 30 days post-procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment by the PC 400 coils Device: PC 400 coils

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  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 ClinicalTrials.gov identifier: NCT01754051

Contacts
Contact: Olivier Sallem, PhD 33 6 82 33 05 06 osellam@penumbrainc.com
Contact: Siu Po Sit, PhD 510748 3200 ext 221 siupo.sit@penumbrainc.com

Locations
France
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.
Investigators
Principal Investigator: Prof. Laurent Pierot, MD CHU Reims - Hôpital Maison Blanche
  More Information

No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01754051     History of Changes
Other Study ID Numbers: CLP 4818, CLP 4818
Study First Received: December 17, 2012
Last Updated: February 19, 2014
Health Authority: France: Comité de Protection des Personnes (CPP) Ile de France 1

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014