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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 2 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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.

Trial locations and contacts

12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

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

Being tested

BALT medical devices

Keywords

catheter, guidewire

Medical subject headings

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• BALT medical devicesDevice

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: From the procedure to 12 months post-procedure depending on the device family.

2. 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.

   Measured: From the procedure to 12 months post-procedure depending on the device family.

3. 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.

   Measured: From the procedure to 12 months post-procedure depending on the device family.

4. 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.

   Measured: From the procedure to 12 months post-procedure depending on the device family.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Jun 2021
2. Study start12 Jul 2021
3. Primary completionJun 2041 (estimated)
4. Study completionOct 2041 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.