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Recruiting NCT04927156

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

— Observational Intracranial Aneurysm Brain Arterial Disease Acute Ischemic Stroke Peripheral Vascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BALT medical devices.
Who it may be relevant to
Registry conditions: Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Germany, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Device 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

Primary outcome measures

  • Rate of occurrence of device-specific safety indicator(s). [Time frame: From the procedure to 12 months post-procedure depending on the device family.]
  • Rate of devices achieving its intended use. [Time frame: From the procedure to 12 months post-procedure depending on the device family.]
  • Rate of devices achieving its specific performance indicator(s). [Time frame: From the procedure to 12 months post-procedure depending on the device family.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 6 centers
  • CHU Angers — Angers
  • Chu Bordeaux — Bordeaux
  • CHU Grenoble Alpes — La Tronche
  • Hôpital Roger Salengro — Lille
  • Kremlin Bicêtre - APHP — Paris
  • Chu Tours — Tours
Spain · 5 centers
  • Hospital: Fundacion Jimenez Diaz — Madrid
  • Hospital Clinico Universitario San Carlos — Madrid
  • Unversitario Central de Asturias — Oviedo
  • Hospital Universitario Marqués de Valdecilla (HUMV) — Santander
  • Hospital Universitario Miguel Servet — Zaragoza
Germany · 1 center
  • Halle — Halle

Identifiers

NCT: NCT04927156 · CIP-202002-BALT DEVICES

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗