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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beacon Tip Catheters | Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter & Shuttle Select Slip-Catheter (Visceral and Cerbral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The percent of patients with freedom from catheter-related major complications | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Breakthroughs | Darien | Connecticut | 06820 | United States |
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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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D020300 | Intracranial Hemorrhages |
| D020521 | Stroke |
| D054079 | Vascular Malformations |
| D017541 | Aneurysm, False |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |