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

NCT06986954 — Completed, 816 participants, Cook Research Incorporated

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Registry	NCT06986954
Status	Completed
Study type	Observational
Enrollment	816 (Actual)
Sponsor	Cook Research Incorporated (Industry)
Conditions	Stenosis, Bleed Intracranial, Stroke, TIA, Vascular Malformation, Pseudoaneurysm
Interventions	Beacon Tip Catheters (Device)
Dates	start 2025-04-20, primary completion 2026-03-04, completion 2026-03-04, first posted 2025-05-23, last updated 2026-07-06
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Beacon Tip Catheters		Device: Beacon Tip Catheters	Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral)

Beacon Tip Catheters (Device): Indicated for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and wire guides should be employed. Beacon Tip Sizing Catheters have marker bands that can be used for anatomical measurements.

+Outcome measures

Primary outcomes

Successful navigation to the intended location [Duration of the procedure (approx. 1 hour)]: The primary performance outcome is successful navigation to the intended location The percent of successful navigation to the intended location
Successful intended use [Duration of the procedure (approx. 1 hour)]: Successful intended use (e.g. release of contrast agent (if applicable), successful anatomical sizing (if applicable)), after successful navigation to the intended location
Freedom from catheter-related major complications [up to 30 days]: The primary safety outcome is freedom from catheter-related major complications. Major complications are defined as those that: * Require therapy, minor hospitalization (<48 hours); * Require major therapy, unplanned increase in level of care, prolonged hospitalization; * Have permanent adverse sequelae; or result in death. The percent of patients with freedom from catheter-related major complications

+Eligibility

Sex: All

Inclusion Criteria:

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

Exclusion Criteria:

* 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).

+Locations (1)

Facility	City	Country	Status
Vascular Breakthroughs	Darien, Connecticut	United States