Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

NCT ID: NCT04927156

Last Updated: 2025-09-18

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

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-12

Study Completion Date

2041-10-31

Brief Summary

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BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.

This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.

Detailed Description

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Conditions

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Intracranial Aneurysm Brain Arterial Disease Acute Ischemic Stroke Peripheral Vascular Diseases AVM - Cerebral Arteriovenous Malformation AVM Fistulas Arteriovenous

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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BALT medical devices

BALT medical devices

Intervention Type DEVICE

Includes, but is not limited to, the following:

* Access devices
* Aneurysm treatment devices
* Ischemic Stroke and peripheral occlusive diseases treatment devices
* Arterio-Venous Malformations/fistulas treatment devices

Interventions

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BALT medical devices

Includes, but is not limited to, the following:

* Access devices
* Aneurysm treatment devices
* Ischemic Stroke and peripheral occlusive diseases treatment devices
* Arterio-Venous Malformations/fistulas treatment devices

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Provision of a signed, written and dated informed consent or non-opposition (where applicable)

Exclusion Criteria

* Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)
* Contra-indications of each device as described in the instructions for use.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balt Extrusion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status RECRUITING

Chu Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHU Grenoble Alpes

La Tronche, , France

Site Status RECRUITING

Hôpital Roger Salengro

Lille, , France

Site Status RECRUITING

Kremlin Bicêtre - APHP

Paris, , France

Site Status RECRUITING

Chu Tours

Tours, , France

Site Status RECRUITING

Halle

Halle, , Germany

Site Status RECRUITING

Hospital: Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico Universitario San Carlos

Madrid, , Spain

Site Status TERMINATED

Unversitario Central de Asturias

Oviedo, , Spain

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla (HUMV)

Santander, , Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status NOT_YET_RECRUITING

Countries

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France Germany Spain

Central Contacts

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Clinical Affairs Department

Role: CONTACT

+33 1 39 89 46 41

Facility Contacts

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Tristan KERDRAON

Role: primary

Julien DUCASSE

Role: primary

Dr Bibi

Role: primary

zhanna Svatko

Role: primary

Related Links

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Other Identifiers

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CIP-202002-BALT DEVICES

Identifier Type: -

Identifier Source: org_study_id

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