RecruitingNCT04927156

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

Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection


Sponsor

Balt Extrusion

Enrollment

10,000 participants

Start Date

Jul 12, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 Years

Inclusion Criteria1

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

Exclusion Criteria2

  • 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.

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Interventions

DEVICEBALT 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


Locations(12)

CHU Angers

Angers, France

Chu Bordeaux

Bordeaux, France

CHU Grenoble Alpes

La Tronche, France

Hôpital Roger Salengro

Lille, France

Kremlin Bicêtre - APHP

Paris, France

Chu Tours

Tours, France

Halle

Halle, Germany

Hospital: Fundacion Jimenez Diaz

Madrid, Spain

Hospital Clinico Universitario San Carlos

Madrid, Spain

Unversitario Central de Asturias

Oviedo, Spain

Hospital Universitario Marqués de Valdecilla (HUMV)

Santander, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

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NCT04927156


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