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Safety and Feasibility of the Infinity Catheter for Radial Access

NCT04553549 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-12-11

No results posted yet for this study

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.

Conditions

  • Brain Tumor
  • Stroke, Acute
  • Brain Aneurysm
  • Intracranial Arteriovenous Malformations
  • Carotid Stenosis
  • Cavernous Sinus Thrombosis

Interventions

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).

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Priyank Khandelwal, MD · Rutgers University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-09-15
Completion
2022-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553549 on ClinicalTrials.gov