Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCook Research Incorporated
About this trial
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
This trial does not accept healthy volunteersQualifiers
A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.
Disqualifiers
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 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Beacon Tip Catheters
DeviceIndicated 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.
Treatment groups
588 Participants
are divided into 1 treatment groupGroup A: Beacon Tip Catheters1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Duration of the procedure (approx. 1 hour)2
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
Time frame
Duration of the procedure (approx. 1 hour)3
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
Time frame
up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov