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

Phase

N/A

Condition

Occlusions

Stroke

Abnormal Blood Vessels (Arteriovenous Malformations)

Treatment

Beacon Tip Catheters

Clinical Study ID

NCT06986954

24-01

All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Beacon Tip Catheters

April 20, 2025

July 31, 2026

Connect with a study center

Vascular Breakthroughs
Darien, Connecticut 06820
United States
Active - Recruiting

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