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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754051
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : May 17, 2018
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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