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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.

Study Description
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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
Intracranial Aneurysms Device: PC 400 coils

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
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
Study Start Date : January 2013
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Packing density with the number of coils implanted [ Time Frame: During the procedure ]
  2. Time of fluoroscopic exposure [ Time Frame: During the procedure ]
  3. Procedural device-related serious adverse events at immediate post-procedure [ Time Frame: During the procedure ]
  4. 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 :
  1. Acute occlusion of the aneurysm sac at immediate post-procedure [ Time Frame: At immediate post-procedure ]
  2. Adverse events occurring during the procedure and in the 30±7 days following the treatment. [ Time Frame: During and at 30 days post-procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754051


Locations
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France
CHU Pellegrin
Bordeaux, France
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Dr. Jérôme Berge, MD CHU Pellegrin - Bordeaux
More Information
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Additional Information:

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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01754051    
Other Study ID Numbers: CLP 4818
CLP 4818 ( Other Identifier: Penumbra Inc )
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases