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

Recruiting now

Conditions studied: Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases, AVM - Cerebral Arteriovenous Malformation, AVM, Fistulas Arteriovenous

In brief

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.

Key facts

Study ID

NCT04927156

Run by

Balt Extrusion

People needed

10000

Starts

2021-07-12

Expected to finish

2041-10-01

Last updated by the study team

2025-09-18

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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