Clinical trial NCT04927156: Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Brain Arterial Disease
Acute Ischemic Stroke
Peripheral Vascular Diseases
AVM - Cerebral Arteriovenous Malformation
AVM
Lead sponsor: Balt Extrusion
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include the BALT medical devices under consideration used in their respective indications for use during interventions performed at the participating sites.

Brief 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 criteria: 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 outcomes:
measure: Rate of occurrence of device-specific safety indicator(s).
timeFrame: From the procedure to 12 months post-procedure depending on the device family.
measure: Rate of devices achieving its intended use.
timeFrame: From the procedure to 12 months post-procedure depending on the device family.
measure: Rate of devices achieving its specific performance indicator(s).
timeFrame: From the procedure to 12 months post-procedure depending on the device family.
measure: Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator
timeFrame: From the procedure to 12 months post-procedure depending on the device family.
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: Chu Bordeaux
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Paris
country: France
facility: Kremlin Bicêtre - APHP
city: Tours
country: France
facility: Chu Tours
city: Halle
country: Germany
facility: Halle
city: Madrid
country: Spain
facility: Hospital: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital: Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Oviedo
country: Spain
facility: Unversitario Central de Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla (HUMV)
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References: