Safety and Feasibility of the Infinity Catheter for Radial Access
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|ClinicalTrials.gov Identifier: NCT04553549|
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : November 20, 2020
|Condition or disease||Intervention/treatment|
|Brain Tumor Stroke, Acute Brain Aneurysm Intracranial Arteriovenous Malformations Carotid Stenosis Cavernous Sinus Thrombosis||Device: Transradial approach|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Safety and Feasibility of the Infinity Guide Catheter for Neuro Interventional Procedures Using Transradial Access|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||September 30, 2022|
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).
Device: Transradial 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).
- Feasibility of TRA Intervention [ Time Frame: 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.
- Assess radial artery occlusion rates post procedure [ Time Frame: 1 month ]Reverse Barbue Test and ultrasound
- Demographics [ Time Frame: 1 month ]Patient demographics will be analyzed such as past medical history, HTN, HLD, Afib
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553549
|Contact: Priyank Khandelwal, MDemail@example.com|
|United States, New Jersey|
|Newark, New Jersey, United States, 07101|
|Contact: Priyank Khandelwal, MD|
|Principal Investigator:||Priyank Khandelwal, MD||Rutgers New Jersey Medical School|