Bleed Intracranial, Pseudoaneurysm, Stenosis, Stroke, TIA, Vascular Malformation
Conditions
Keywords
Catheter, Beacon, Diagnostic imaging, Device sizing, Beacon tip slip cath
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.
Interventions
DEVICEBeacon 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.
Sponsors
Cook Research Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful navigation to the intended location | Duration of the procedure (approx. 1 hour) | The primary performance outcome is successful navigation to the intended location The percent of successful navigation to the intended location |
| Successful intended use | Duration of the procedure (approx. 1 hour) | Successful intended use (e.g. release of contrast agent (if applicable), successful anatomical sizing (if applicable)), after successful navigation to the intended location |
| Freedom from catheter-related major complications | up to 30 days | 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 |
Countries
United States
Outcome results
None listed