NCT06986954

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 588 (estimated)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Stenosis
• Bleed Intracranial
• Stroke
• TIA
• Vascular Malformation
• Pseudoaneurysm

Interventions

Type	Name	Description
DEVICE	Beacon Tip Catheters	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.

Timeline

• Start date: 2025-04-20
• Primary completion: 2026-04-30
• Completion: 2026-07-31
• First posted: 2025-05-23
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States