Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study

What this Trial Is About

This observational clinical study is designed to collect data in the United States to support the re-launch and regulatory approval of the redesigned Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter Shuttle Select Slip-Catheter. The study focuses on evaluating these devices used in angiographic procedures for conditions such as stenosis, intracranial bleeding, stroke, TIA, vascular malformation, and pseudoaneurysm. The purpose is to assess safety and performance according to their intended use. Participants will undergo procedures using the Beacon Tip Catheters, which are designed for use by physicians trained in angiographic techniques. These catheters include marker bands for anatomical measurements and are used with standard vascular access methods. The study monitors use through the end of the index procedure and up to 30 days post-procedure to collect relevant safety and performance data. During the study, researchers will track successful navigation of the catheter to the intended location and whether the catheter performs as intended during the approximately one-hour procedure. They will also monitor for any major catheter-related complications up to 30 days after the procedure. Participant involvement primarily includes the procedure itself and follow-up monitoring to assess outcomes and safety over this time frame.

Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study