StenosisNCT06986954
Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
An observational study of Stenosis and Bleed Intracranial, run by Cook Research Incorporated at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stenosis, Bleed Intracranial, Stroke
- What is being tested?
- Beacon Tip Catheters
- Type of treatment
- Medical device
- How many people
- 816 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2025to 4 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Beacon Tip Catheters
- Keywords
- Catheter, Beacon, Diagnostic imaging, Device sizing, Beacon tip slip cath
- Medical subject headings
- Constriction, Pathologic, Intracranial Hemorrhages, Stroke, Vascular Malformations, Aneurysm, False
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beacon Tip CathetersDevice
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 group | Role | What they receive |
|---|---|---|
| Beacon Tip Catheters | Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral) Receives: Device: Beacon Tip Catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start20 Apr 2025
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986954
- Sponsor's protocol ID
- 24-01
- Status last verified
- Jul 2026
- First submitted
- 8 May 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study
- ClinicalTrials.gov ID
- NCT06986954
- Acronym / sponsor ID
- 24-01
- Conditions
- Stenosis, Bleed Intracranial, Stroke, TIA, Vascular Malformation, Pseudoaneurysm
- Keywords
- Catheter, Beacon, Diagnostic imaging, Device sizing, Beacon tip slip cath
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beacon Tip Catheters | – | Device: Beacon Tip CathetersBeacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beacon Tip CathetersIndicated 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. | Device | Beacon Tip Catheters |
Primary outcome
Successful navigation to the intended location
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenosis and Bleed Intracranial, run by Cook Research Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful navigation to the intended location (time frame: Duration of the procedure (approx. 1 hour)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.