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

Recruiting

• Conditions: AVM; Intracranial Aneurysm; Acute Ischemic Stroke; AVM - Cerebral Arteriovenous Malformation; Peripheral Vascular Diseases; Brain Arterial Disease
• Interventions: Device: BALT medical devices

• Registration Number: NCT04927156
• Lead Sponsor: Balt Extrusion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-15
• Study Start: 2021-07-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2041-06
• Study Completion: 2041-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BALT medical devices	BALT medical devices	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (13)

Unversitario Central de Asturias; 🇪🇸 Oviedo, Spain

CHU Grenoble Alpes; 🇫🇷 La Tronche, France

CHU Angers; 🇫🇷 Angers, France

Chu Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Roger Salengro; 🇫🇷 Lille, France

Hospital: Puerta de Hierro; 🇪🇸 Madrid, Spain

Halle; 🇩🇪 Halle, Germany

Kremlin Bicêtre - APHP; 🇫🇷 Paris, France

Hospital: Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Clinico Universitario San Carlos; 🇪🇸 Madrid, Spain

Chu Tours; 🇫🇷 Tours, France

Hospital Universitario Marqués de Valdecilla (HUMV); 🇪🇸 Santander, Spain