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

NCT04927156 | Recruiting FDA Device

• 1 other identifier: CIP-202002-BALT DEVICES
• Study Type: observational
• Target: 10,000
• Locations: 3 countries
• Sites: 12

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.

Conditions

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

Keywords

catheter; guidewire

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

BALT medical devices

Device: BALT medical devices

Interventions

BALT medical devices DEVICE

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

BALT medical devices

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Provision of a signed, written and dated informed consent or non-opposition (where applicable)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balt Extrusion: lead

Study Sites (12)

CHU Angers

Angers, France

RECRUITING

Chu Bordeaux

Bordeaux, France

RECRUITING

CHU Grenoble Alpes

La Tronche, France

RECRUITING

Hôpital Roger Salengro

Lille, France

RECRUITING

Kremlin Bicêtre - APHP

Paris, France

RECRUITING

Chu Tours

Tours, 37000, France

RECRUITING

Halle

Halle, Germany

RECRUITING

Hospital: Fundacion Jimenez Diaz

Madrid, 28222, Spain

RECRUITING

Hospital Clinico Universitario San Carlos

Madrid, Spain

TERMINATED

Unversitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla (HUMV)

Santander, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

NOT YET RECRUITING

Related Links

• HDH

MeSH Terms

Conditions

Intracranial Aneurysm; Intracranial Arterial Diseases; Ischemic Stroke; Peripheral Vascular Diseases; Intracranial Arteriovenous Malformations; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Stroke; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Affairs Department

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 15, 2021
• Study Start: July 12, 2021
• Primary Completion (Estimated): June 1, 2041
• Study Completion (Estimated): October 1, 2041
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

FR (6); ES (5); DE (1)