Actively Recruiting
Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
Led by Cook Research Incorporated · Updated on 2025-07-16
588
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient undergoes a procedure using an applicable Beacon Tip Catheter
You will not qualify if you...
- Patient or legally authorized representative objects to data collection or use of consent waiver or data protection notice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 hour
Participants undergo angiographic procedures using Beacon Tip Catheters.
1 procedure visit (in-person)
Duration - Up to 30 days
Participants are monitored for catheter-related complications after the procedure.
Follow-up visits as needed during 30 days
Trial Site Locations
Total: 1 location
1
Vascular Breakthroughs
Darien, Connecticut, United States, 06820
Actively Recruiting
Research Team
H
Hannah Kay
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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