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Clinical Trials in Germany / NCT04927156
Recruiting Observational

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

NCT04927156 · tracked via the Priya Life Science Germany tracker
Sponsor
Balt Extrusion
Phase
Observational
Started
2021-07-12
Last updated
2025-09-18

Condition(s) studied

Intracranial AneurysmBrain Arterial DiseaseAcute Ischemic StrokePeripheral Vascular DiseasesAVM - Cerebral Arteriovenous MalformationAVMFistulas Arteriovenous

Investigational drug(s) / intervention(s)

BALT medical devices

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

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of occurrence of device-specific safety indicator(s). — From the procedure to 12 months post-procedure depending on the device family.
    Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
  • Rate of devices achieving its intended use. — From the procedure to 12 months post-procedure depending on the device family.
    Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
  • Rate of devices achieving its specific performance indicator(s). — From the procedure to 12 months post-procedure depending on the device family.
    Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
  • Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator — From the procedure to 12 months post-procedure depending on the device family.
    Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.

Trial sites (12)

FacilityCityRegionStatus
CHU Angers Angers France Recruiting
Chu Bordeaux Bordeaux France Recruiting
CHU Grenoble Alpes La Tronche France Recruiting
Hôpital Roger Salengro Lille France Recruiting
Kremlin Bicêtre - APHP Paris France Recruiting
Chu Tours Tours France Recruiting
Halle Halle Germany Recruiting
Hospital: Fundacion Jimenez Diaz Madrid Spain Recruiting
Hospital Clinico Universitario San Carlos Madrid Spain Terminated
Unversitario Central de Asturias Oviedo Spain Recruiting
Hospital Universitario Marqués de Valdecilla (HUMV) Santander Spain Recruiting
Hospital Universitario Miguel Servet Zaragoza Spain Not Yet Recruiting

More Balt Extrusion trials in Germany

Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment Active, not recruiting

Other trials for the same condition

LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment Active, not recruiting
Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment Active, not recruiting
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE) Recruiting
Neurovascular Product Surveillance Registry Recruiting
Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04927156 on ClinicalTrials.gov ↗ ← All trials in Germany