TRUfill®'s Line in Intracranial aNeurysm Embolisation

NCT ID: NCT01503775

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-01

Study Completion Date

2014-08-01

Brief Summary

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The objective of this study is to evaluate the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical practice.

Detailed Description

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Conditions

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Aneurysms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TRUFILL® DCS Orbit Galaxy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient ≥ 18 years old
* Patient presenting one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography
* Patient implanted with one or more CODMAN TRUFILL® coils
* Patient agree to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter.

Exclusion Criteria

* Patient who does not accept to take part in the study after being informed
* Patient already enrolled in a clinical trial involving experimental medication or device.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Codman & Shurtleff

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Hopitaux Civils de Colmar

Colmar, , France

Site Status

Hôpital Neurologique

Lyon, , France

Site Status

Clinique Clairval

Marseille, , France

Site Status

Hôpital Adullte La Timone

Marseille, , France

Site Status

Fondation Rothschild

Paris, , France

Site Status

CHU Pontchaillou

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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NV-PMK-0902

Identifier Type: -

Identifier Source: org_study_id

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