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

NCT04927156 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Balt Extrusion

    lead INDUSTRY

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2041-06-30
Completion
2041-10-31
FDA Device
Yes

Countries

  • France
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04927156 on ClinicalTrials.gov