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

September 16, 2025 updated by: Balt Extrusion

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Principal Investigator:
          • Anne PASCO PAPON, MD
      • Bordeaux, France
      • La Tronche, France
        • Recruiting
        • Chu Grenoble Alpes
        • Principal Investigator:
          • Kamel Boubagra, MD
      • Lille, France
        • Recruiting
        • Hopital Roger Salengro
        • Principal Investigator:
          • Nicolas Bricout, MD
        • Sub-Investigator:
          • Estrade
      • Paris, France
        • Recruiting
        • Kremlin Bicêtre - APHP
        • Principal Investigator:
          • Laurent Spelle
        • Contact:
      • Tours, France, 37000
        • Recruiting
        • CHU Tours
        • Contact:
          • Dr Bibi
        • Principal Investigator:
          • Dr Bibi
  • Germany
      • Halle, Germany
  • Spain
      • Madrid, Spain, 28222
        • Recruiting
        • Hospital: Fundacion Jimenez Diaz
        • Principal Investigator:
          • Eduardo Crespo, MD
        • Principal Investigator:
          • Claudio Rodriguez, MD
      • Madrid, Spain
        • Terminated
        • Hospital Clinico Universitario San Carlos
      • Oviedo, Spain, 33011
        • Recruiting
        • Unversitario Central de Asturias
        • Principal Investigator:
          • Pedro Vega, MD
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla (HUMV)
        • Principal Investigator:
          • Andrés Gonzalez Mandly
        • Sub-Investigator:
          • Enrique Montes
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Universitario Miguel Servet
        • Principal Investigator:
          • Rosario Barrena, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
BALT medical devices
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of occurrence of device-specific safety indicator(s).
Time Frame: 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.
From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its intended use.
Time Frame: 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.
From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its specific performance indicator(s).
Time Frame: 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.
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
Time Frame: 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.
From the procedure to 12 months post-procedure depending on the device family.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balt Extrusion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2041

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2041

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-202002-BALT DEVICES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings