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Safety and Feasibility of the Infinity Catheter for Radial Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553549
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Priyank Khandelwal, MD, Rutgers, The State University of New Jersey

Brief 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.

Condition or disease Intervention/treatment
Brain Tumor Stroke, Acute Brain Aneurysm Intracranial Arteriovenous Malformations Carotid Stenosis Cavernous Sinus Thrombosis Device: Transradial approach

Detailed Description:
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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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
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).




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are undergoing endovascular intervention will be enrolled into the study.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Priyank Khandelwal, MD 973-972-4692 pk544@njms.rutgers.edu

Locations
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United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07101
Contact: Priyank Khandelwal, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Priyank Khandelwal, MD Rutgers New Jersey Medical School
Publications:

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Responsible Party: Priyank Khandelwal, MD, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04553549    
Other Study ID Numbers: Pro2020000869
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate data will be presented

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Priyank Khandelwal, MD, Rutgers, The State University of New Jersey:
neuro-embolization
Additional relevant MeSH terms:
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Stroke
Carotid Stenosis
Intracranial Aneurysm
Sinus Thrombosis, Intracranial
Intracranial Arteriovenous Malformations
Cavernous Sinus Thrombosis
Thrombosis
Arteriovenous Malformations
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Congenital Abnormalities
Cerebrovascular Disorders
Vascular Malformations
Cardiovascular Abnormalities
Carotid Artery Diseases
Arterial Occlusive Diseases
Intracranial Arterial Diseases
Intracranial Thrombosis
Intracranial Embolism and Thrombosis
Thromboembolism
Central Nervous System Vascular Malformations
Nervous System Malformations