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

Recruiting

• Conditions: Stenosis; Bleed Intracranial; Stroke; TIA; Vascular Malformation; Pseudoaneurysm

• Registration Number: NCT06986954
• Lead Sponsor: Cook Research Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-30
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 588

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Vascular Breakthroughs; 🇺🇸 Darien, Connecticut, United States