Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE (ANCRAGE PMS)

April 16, 2025 updated by: Acandis GmbH

ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE

The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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 Contact

Study Locations

  • France
      • Rouen, France, 76000
        • Recruiting
        • Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)
        • Contact:
          • Chrysanthi Papagiannaki, Dr.
          • Phone Number: +33 2 32 88 89 90

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Each cohort will consist of subjects with an intracranial aneurysm whom the physician wishes to treat with one or more Acandis devices.

Each subject will be followed according to the standard of care within the participating sites.

All treated (and intended to treat with at least 1 Acandis device inserted) cases will be captured in the ANCRAGE study database, from the date of agreement with French authorities; that means it will be a consecutive prospective enrollment to demonstrate the exhaustivity at the site, even the cases are captured in the database retrospectively.

There is a minimum of 50 consecutive cases to be enrolled per device family, from the time the device has been put on the French market and until the needed report to the authorities (for instance the renewal of the device registration/reimbursement).

Description

Inclusion Criteria:

  • The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms.
  • The subject is 18 years of age or older.
  • The subject is willing to comply with scheduled visits and examinations, per institution standard of care.

Exclusion Criteria:

  • The subject has provided tacit opposition to data collection.
  • Any IFU warning will be considered for exclusion in the cohort.

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
Devices of the DERIVO family
ACCLINO flex plus Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation
Time Frame: 12+/-3 months after treatment
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation, defined as a mRS >/= 3 for the subjects with a baseline mRS between 0 and 2 or mRS increase of 1 point for subjects with a baseline mRS greater than 2.
12+/-3 months after treatment

Collaborators and Investigators

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

Sponsor

Acandis GmbH

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 (Actual)

December 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANCRAGE PMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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