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

Balt

Status: Enrolling

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

Treatments: Device: BALT medical devices

Study type: Observational

Funder types: Industry

Identifiers

NCT04927156

CIP-202002-BALT DEVICES

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

10,000 participants in 1 patient group

BALT medical devices

Treatment:

Device: BALT medical devices