RECRUITINGOBSERVATIONAL
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Provision of a signed, written and dated willing to sign a consent form 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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 (12)
CHU Angers
Angers, France
Chu Bordeaux
Bordeaux, France
CHU Grenoble Alpes
La Tronche, France
Hôpital Roger Salengro
Lille, France
Kremlin Bicêtre - APHP
Paris, France
Chu Tours
Tours, France
Halle
Halle, Germany
Hospital: Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
Unversitario Central de Asturias
Oviedo, Spain
Hospital Universitario Marqués de Valdecilla (HUMV)
Santander, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain