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NCT Number: NCT04927156

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

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.

Recruiting

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Key information

Conditions

Intracranial Aneurysm AVM AVM - Cerebral Arteriovenous Malformation Acute Ischemic Stroke Aneurysm Arteriovenous Fistula Arteriovenous Malformations Brain Arterial Disease Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Fistulas Arteriovenous Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Ischemic Stroke Nervous System Diseases Nervous System Malformations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Stroke Vascular Diseases Vascular Fistula Vascular Malformations

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

BALT medical devices

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

Primary outcomes

  1. Rate of occurrence of device-specific safety indicator(s).

    Time frame: From the procedure to 12 months post-procedure depending on the device family.

    Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.

  2. Rate of devices achieving its intended use.

    Time frame: From the procedure to 12 months post-procedure depending on the device family.

    Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.

  3. Rate of devices achieving its specific performance indicator(s).

    Time frame: From the procedure to 12 months post-procedure depending on the device family.

    Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.

  4. Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator

    Time frame: From the procedure to 12 months post-procedure depending on the device family.

    Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Affairs Department

CONTACT

[email protected]

+33 1 39 89 46 41

Sponsors and collaborators

Lead sponsor

Balt Extrusion

Industry

Registry information

Official study title

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

Acronym: EVIDENCE

Important dates

Study start
2021
Primary completion
2041
Study completion
2041
First posted
Jun 15, 2021
Registry last updated
Sep 18, 2025

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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