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

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04927156
• Other study ID #: CIP-202002-BALT DEVICES
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: October 2041

Study information

• Verified date: February 2023
• Source: Balt Extrusion
• Contact: Clinical Affairs Department
• Phone: +33 1 39 89 46 41
• Email: Evidence[@]baltgroup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 2041
• Est. primary completion date: June 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Arteriovenous Malformations
• AVM
• AVM - Cerebral Arteriovenous Malformation
• Intracranial Aneurysm
• Intracranial Arterial Diseases
• Intracranial Arteriovenous Malformations
• Ischemic Stroke
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Grenoble Alpes	La Tronche
France	Hôpital Roger Salengro	Lille
France	Chu Tours	Tours
Spain	Hospital Clinico Universitario San Carlos	Madrid
Spain	Hospital: Fundacion Jimenez Diaz	Madrid
Spain	Hospital: Puerta de Hierro	Madrid
Spain	Unversitario Central de Asturias	Oviedo
Spain	Hospital Universitario Marqués de Valdecilla (HUMV)	Santander
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Balt Extrusion

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of occurrence of device-specific safety indicator(s).	Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.	From the procedure to 12 months post-procedure depending on the device family.
Primary	Rate of devices achieving its intended use.	Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.	From the procedure to 12 months post-procedure depending on the device family.
Primary	Rate of devices achieving its specific performance indicator(s).	Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.	From the procedure to 12 months post-procedure depending on the device family.
Primary	Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator	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.	From the procedure to 12 months post-procedure depending on the device family.