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

Cook Group

Status: Enrolling

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

Treatments: Device: Beacon Tip Catheters

Study type: Observational

Funder types: Industry

Identifiers

NCT06986954

24-01

Details and patient eligibility

About

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.

Enrollment: 588 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

588 participants in 1 patient group

Beacon Tip Catheters

Description:

Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral)

Treatment:

Device: Beacon Tip Catheters