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Taking people in SpainNo phase

Follows patients treated with BALT devices for brain artery conditions

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

Plain-language title generated from the registry record
Registry title: Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

Key facts

Where
Madrid, Oviedo, Santander, and Zaragoza, SpainSee the 5 sites

AI summary: who the study is looking for

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

Read by machine on 12 November 2026.

Where in Spain

  • Hospital Fundación Jimenez DiazMadrid, SpainContact: Eduardo Crespo, MD (principal investigator)Taking people
  • Hospital Clínico Universitario San CarlosMadrid, SpainContact: Clinical Affairs DepartmentNo longer taking part
  • Unversitario Central de AsturiasOviedo, SpainContact: Pedro Vega, MD (principal investigator)Taking people
  • Hospital Universitario Marques de Valdecilla (HUMV)Santander, SpainContact: Andrés Gonzalez Mandly (principal investigator)Taking people
  • Hospital Universitario Miguel ServetZaragoza, SpainContact: Rosario Barrena, MD (principal investigator)Not yet recruiting

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

Trial details

Who runs it
Balt Extrusion
Trial code
NCT04927156
Record updated
18 September 2025
Original description
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

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

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.

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

Exclusion: 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.

ClinicalTrials.gov NCT04927156