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

Part of paid clinical trials in Darien, Connecticut.

Sponsor
Cook Research Incorporated
Study ID
NCT06986954
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 20, 2025
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
588 participants (estimated)

Arms

  • Arm: Beacon Tip Catheters
    Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral)

Primary Outcome Measure

Successful navigation to the intended location [ Time Frame: Duration of the procedure (approx. 1 hour) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vascular BreakthroughsDarienConnecticut06820
David Rasmussen, MD
[email protected]
617-829-3386

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