Trials / Recruiting
RecruitingNCT04927156
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,000 (estimated)
- Sponsor
- Balt Extrusion · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-07-12
- Primary completion
- 2041-06-01
- Completion
- 2041-10-01
- First posted
- 2021-06-15
- Last updated
- 2025-09-18
Locations
12 sites across 3 countries: France, Germany, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04927156. Inclusion in this directory is not an endorsement.