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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transradial approach | The procedure will be done using standard criteria as per operator preference. All interventional cases at our 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transradial approach | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of TRA Intervention | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Assess radial artery occlusion rates post procedure | Reverse Barbue Test and ultrasound | 1 month |
| Demographics | Patient demographics will be analyzed such as past medical history, HTN, HLD, Afib |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are undergoing endovascular intervention will be enrolled into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Priyank Khandelwal, MD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19081409 | Background | Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1. | |
| 20965460 | Background |
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Aggregate data will be presented
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2020 | Nov 1, 2023 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2020 | Nov 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D020521 | Stroke |
| D002532 | Intracranial Aneurysm |
| D002538 | Intracranial Arteriovenous Malformations |
| D016893 | Carotid Stenosis |
| D020226 | Cavernous Sinus Thrombosis |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 1 month |
| Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodes-Cabau J, Larose E, Costerousse O, Hamon M, Mann T. Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey. JACC Cardiovasc Interv. 2010 Oct;3(10):1022-31. doi: 10.1016/j.jcin.2010.07.013. |
| 23354100 | Background | Hamon M, Pristipino C, Di Mario C, Nolan J, Ludwig J, Tubaro M, Sabate M, Mauri-Ferre J, Huber K, Niemela K, Haude M, Wijns W, Dudek D, Fajadet J, Kiemeneij F; European Association of Percutaneous Cardiovascular Interventions; Working Group on Acute Cardiac Care of the European Society of Cardiology; Working Group on Thrombosis on the European Society of Cardiology. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care** and Thrombosis of the European Society of Cardiology. EuroIntervention. 2013 Mar;8(11):1242-51. doi: 10.4244/EIJV8I11A192. |
| 29665617 | Background | Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2. |
| 29311120 | Background | Snelling BM, Sur S, Shah SS, Khandelwal P, Caplan J, Haniff R, Starke RM, Yavagal DR, Peterson EC. Transradial cerebral angiography: techniques and outcomes. J Neurointerv Surg. 2018 Sep;10(9):874-881. doi: 10.1136/neurintsurg-2017-013584. Epub 2018 Jan 8. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000783 | Aneurysm |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002340 | Carotid Artery Diseases |
| D001157 | Arterial Occlusive Diseases |
| D000096826 | Cavernous Sinus Syndromes |
| D012851 | Sinus Thrombosis, Intracranial |
| D020767 | Intracranial Thrombosis |
| D002542 | Intracranial Embolism and Thrombosis |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |