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

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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Key information

Conditions

Stenosis Aneurysm, False Bleed Intracranial Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constriction, Pathologic Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pseudoaneurysm Stroke TIA Vascular Diseases Vascular Malformation Vascular Malformations

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular Breakthroughs

Darien, Connecticut, 06820, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

Successful navigation to the intended location

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 23, 2025
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed