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Taking people in FranceNo phase

Follows patients treated with BALT devices for brain artery conditions

Collects follow-up data on BALT devices used for brain artery disease.

Key facts

Who runs it
Balt Extrusion
Where
Angers, Bordeaux, La Tronche, Lille, Paris, and Tours, FranceSee the 6 sitesAlso in 2 other countries, 6 sites
Trial code
Registry title
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
Status
Recruiting
People taking part
10,000 people, planned
Started
12 Jul 2021
Expected to end
Oct 2041
Type of study
Observational
Treatments tested
  • BALT medical devices
Record updated
18 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

This platform collects follow-up data on people treated with BALT medical devices for blood vessel conditions in the brain or body. The record lists only consent as an inclusion rule.

Age
2 years and older
Sex
All sexes can join

Main reasons for not taking part

  • Device used in several procedures (two or more diseases treated in the same procedure)
  • Contra-indications of each device listed in its instructions for use

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

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

Who cannot take part

  • 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

Where in France

Also in 2 other countries, 6 sites

  • CHU AngersAngers, FranceContact: Anne PASCO PAPON, MD (principal investigator)Taking people
  • CHU BordeauxBordeaux, FranceContact: Tristan KERDRAONTaking people
  • Chu Grenoble AlpesLa Tronche, FranceContact: Kamel Boubagra, MD (principal investigator)Taking people
  • Hopital Roger SalengroLille, FranceContact: Nicolas Bricout, MD (principal investigator)Taking people
  • Kremlin Bicêtre - APHPParis, FranceContact: Julien DUCASSETaking people
  • CHU ToursTours, FranceContact: Dr BibiTaking people

About the trial

What the trial wants to find out

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

Read full original descriptionShow less

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

The group in the trial

  • BALT medical devices

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Follows patients treated with BALT devices for brain artery conditionsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 September 2025