- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04553549
Safety and Feasibility of the Infinity Catheter for Radial Access
December 4, 2023 updated by: Priyank Khandelwal, MD, Rutgers, The State University of New Jersey
Safety and Feasibility of the Infinity Guide Catheter for Neuro Interventional Procedures Using Transradial 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Priyank Khandelwal, MD
- Phone Number: 973-972-4692
- Email: pk544@njms.rutgers.edu
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07101
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who are undergoing endovascular intervention will be enrolled into the study.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess radial artery occlusion rates post procedure
Time Frame: 1 month
|
Reverse Barbue Test and ultrasound
|
1 month
|
Demographics
Time Frame: 1 month
|
Patient demographics will be analyzed such as past medical history, HTN, HLD, Afib
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Priyank Khandelwal, MD, Rutgers University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodes-Cabau J, Larose E, Costerousse O, Hamon M, Mann T. Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey. JACC Cardiovasc Interv. 2010 Oct;3(10):1022-31. doi: 10.1016/j.jcin.2010.07.013.
- Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.
- Hamon M, Pristipino C, Di Mario C, Nolan J, Ludwig J, Tubaro M, Sabate M, Mauri-Ferre J, Huber K, Niemela K, Haude M, Wijns W, Dudek D, Fajadet J, Kiemeneij F; European Association of Percutaneous Cardiovascular Interventions; Working Group on Acute Cardiac Care of the European Society of Cardiology; Working Group on Thrombosis on the European Society of Cardiology. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care** and Thrombosis of the European Society of Cardiology. EuroIntervention. 2013 Mar;8(11):1242-51. doi: 10.4244/EIJV8I11A192.
- Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2.
- Snelling BM, Sur S, Shah SS, Khandelwal P, Caplan J, Haniff R, Starke RM, Yavagal DR, Peterson EC. Transradial cerebral angiography: techniques and outcomes. J Neurointerv Surg. 2018 Sep;10(9):874-881. doi: 10.1136/neurintsurg-2017-013584. Epub 2018 Jan 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
September 11, 2020
First Posted (Actual)
September 17, 2020
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Congenital Abnormalities
- Embolism and Thrombosis
- Carotid Artery Diseases
- Cardiovascular Abnormalities
- Nervous System Malformations
- Vascular Malformations
- Intracranial Arterial Diseases
- Aneurysm
- Central Nervous System Vascular Malformations
- Intracranial Thrombosis
- Intracranial Embolism and Thrombosis
- Thromboembolism
- Stroke
- Carotid Stenosis
- Thrombosis
- Arteriovenous Malformations
- Intracranial Aneurysm
- Intracranial Arteriovenous Malformations
- Sinus Thrombosis, Intracranial
- Cavernous Sinus Thrombosis
Other Study ID Numbers
- Pro2020000869
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Aggregate data will be presented
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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