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

May 14, 2018 updated by: Penumbra Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Packing density with the number of coils implanted
Time Frame: During the procedure
During the procedure
Time of fluoroscopic exposure
Time Frame: During the procedure
During the procedure
Procedural device-related serious adverse events at immediate post-procedure
Time Frame: During the procedure
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
At 1 year post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute occlusion of the aneurysm sac at immediate post-procedure
Time Frame: At immediate post-procedure
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
During and at 30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penumbra Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 3, 2017

Study Completion (Actual)

October 3, 2017

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP 4818 (Other Identifier: Penumbra Inc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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