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

Completed

Conditions studied: Stenosis, Bleed Intracranial, Stroke, TIA, Vascular Malformation, Pseudoaneurysm

In brief

This prospective observational post-market clinical study will collect data in the United States to primarily support the re-launch of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral) for a Conformité Européenne (CE) Mark application in the European Union (EU). Additionally, the data from this study may be used to support regulatory approval in other countries/regions. The purpose of this clinical study is to evaluate the safety and performance of these catheters in accordance with the Intended Use through the end of index procedure, and through 30 days post procedure, (as applicable as data is available) to ensure an acceptable benefit:risk ratio.

Key facts

Study ID

NCT06986954

Run by

Cook Research Incorporated

People needed

816

Starts

2025-04-20

Expected to finish

2026-03-04

Last updated by the study team

2026-07-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.

You may not qualify if…

• Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to accept the use of an Informed Consent waiver or the data protection notice (if utilized).

Where it is running

• Vascular Breakthroughs — Darien, Connecticut, United States

Full record on ClinicalTrials.gov

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