Safety and Feasibility of the Infinity Catheter for Radial Access

Completed

Conditions studied: Brain Tumor, Stroke, Acute, Brain Aneurysm, Intracranial Arteriovenous Malformations, Carotid Stenosis, Cavernous Sinus Thrombosis

In brief

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.

Key facts

Study ID

NCT04553549

Run by

Rutgers, The State University of New Jersey

People needed

80

Starts

2020-10-01

Expected to finish

2022-10-30

Last updated by the study team

2023-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age group 18 years and above.
• Patients undergoing neuro-embolization using large bore catheters

You may not qualify if…

• 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

Where it is running

• University Hospital — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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