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

NCT06986954 | Recruiting

• 1 other identifier: 24-01
• Study Type: observational
• Target: 588
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Catheter; Beacon; Diagnostic imaging; Device sizing; Beacon tip slip cath

Outcome Measures

Primary Outcomes (3)

• Successful navigation to the intended location

  The primary performance outcome is successful navigation to the intended location The percent of successful navigation to the intended location

  Duration of the procedure (approx. 1 hour)

• Successful intended use

  Successful intended use (e.g. release of contrast agent (if applicable), successful anatomical sizing (if applicable)), after successful navigation to the intended location

  Duration of the procedure (approx. 1 hour)

• Freedom from catheter-related major complications

  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

  up to 30 days

Study Arms (1)

Beacon Tip Catheters

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

Device: Beacon Tip Catheters

Interventions

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.

Beacon Tip Catheters

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population for this study will be patients receiving care at the 8 office-based labs (OBLs) consisting of 14 sites, all part of the Data Collection Center, Vascular Breakthroughs. These patients will not be constrained to a specific demographic, but rather will be any person who undergoes a procedure using a Beacon Tip Catheter(s).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (1)

Vascular Breakthroughs

Darien, Connecticut, 06820, United States

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic; Intracranial Hemorrhages; Stroke; Vascular Malformations; Aneurysm, False

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hannah Kay

CONTACT

800-468-1379; hannah.kay@cookmedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 23, 2025
• Study Start: April 20, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)