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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04927156

Acronym

EVIDENCE

Enrollment

10000

Registered

2021-06-15

Start date

2021-07-12

Completion date

2041-10-31

Last updated

2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

catheter, guidewire

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.

Interventions

DEVICEBALT 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 design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France, Germany, Spain

Contacts

Primary ContactClinical Affairs Department

Evidence@baltgroup.com+33 1 39 89 46 41

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026