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Completed

NCT Number: NCT04553549

Safety and Feasibility of the Infinity Catheter for Radial Access

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.

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Key information

Conditions

Brain Tumor Aneurysm Arterial Occlusive Diseases Arteriovenous Malformations Brain Aneurysm Brain Diseases Brain Neoplasms Cardiovascular Abnormalities Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Cavernous Sinus Syndromes Cavernous Sinus Thrombosis Central Nervous System Diseases Central Nervous System Neoplasms Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Intracranial Aneurysm Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Intracranial Embolism and Thrombosis Intracranial Thrombosis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Sinus Thrombosis, Intracranial Stroke Stroke, Acute Thromboembolism Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Newark, New Jersey, 07101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assess radial artery occlusion rates post procedure

    Time frame: 1 month

    Reverse Barbue Test and ultrasound

  2. Demographics

    Time frame: 1 month

    Patient demographics will be analyzed such as past medical history, HTN, HLD, Afib

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Safety and Feasibility of the Infinity Guide Catheter for Neuro Interventional Procedures Using Transradial Access

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2020
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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