Brain Aneurysm, Brain Tumor, Carotid Stenosis, Cavernous Sinus Thrombosis, Intracranial Arteriovenous Malformations, Stroke, Acute
Conditions
Keywords
neuro-embolization
Brief summary
The main objective of this single arm study is to evaluate the safety and feasibility of the AXS Infinity LS (Stryker, Freemont, CA, USA) and AXS Infinity LS Plus (Stryker, Freemont, CA, USA) catheters during the transradial approach through a secondary use of the data collected during neurointerventional procedures. This includes evaluating the conversion rates to a transfemoral approach. A secondary aim of the study is to assess the radial artery occlusion rates post procedure.
Detailed description
Patients who are undergoing endovascular intervention will be enrolled into the study. Consent will be obtained for the procedure and for the use of their prospectively collected clinical data. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a radial first approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr). If the artery does not meet the size criteria, only a 6Fr sheath will be used, and the data recorded during the procedure will not be utilized for analysis in this study. The preoperative and postoperative care will be the same for all the patients. No tests will be done outside of standard of care.
Interventions
DEVICETransradial approach
Patients who are undergoing endovascular intervention will be enrolled into the study. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a radial first approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr).
Sponsors
Rutgers, The State University of New Jersey
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age group 18 years and above. * Patients undergoing neuro-embolization using large bore catheters
Exclusion criteria
* Patients with Radial artery diameter less than 2.4 mm measured with Ultrasound * Age\<18 * Patients who have previous surgeries at either approach site which precludes the use of one of the approach sites * Patients who has poor collateral circulation, Raynaud's phenomenon, radial loop, brachial or subclavian stenosis, aberrant origin of the subclavian artery * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of TRA Intervention | 1 month | The size of the radial artery will be measured and the transradial approach will be used. Notation will be also be recorded if conversion to TFA is used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess radial artery occlusion rates post procedure | 1 month | Reverse Barbue Test and ultrasound |
| Demographics | 1 month | Patient demographics will be analyzed such as past medical history, HTN, HLD, Afib |
Countries
United States
Outcome results
None listed