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Completed

NCT Number: NCT01754051

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.

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Key information

Conditions

Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Pellegrin

Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PC 400 coils

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

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

Acronym: VOLCAN

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2012
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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