ClinicalTrials.gg
CompletedNCT04553549Updated Dec 11, 2023

Safety and Feasibility of the Infinity Catheter for Radial Access

An observational study in Brain Tumor, Stroke, Acute and Brain Aneurysm, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Rutgers, The State University of New Jersey · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,443 studies in Brain Neoplasms with a site in United States — 229 open to participants now, 352 under way, 18 of them phase 3. Brain Neoplasms · United States.

Enrollment
89th of 191
80 · median 76
Started
2020
with 42 others
Observational
193 of 1,443
36 open now
Registered
1,139th of 1,443
by date

Among the 1,443 studies in Brain Neoplasms with a site in United States, this one is the 89th largest by enrollment of the 191 observational ones that give a count, is one of 43 that started in 2020, is one of 193 observational ones, and was the 1,139th registered.

Brain Neoplasms

2,441 studies on the registry are indexed under Brain Neoplasms; 541 are open to participants now.

Browse Brain Neoplasms studies →

Open to participants now

229 of the 1,443 studies in Brain Neoplasms with a site in United States are open now. Recruiting first, the newest first:

224 more — sign in →

All 229 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 424 Brain Neoplasms studies recruiting now, 285 (67%) set no upper age limit and 82 (19%) stop at 75 or younger; 80 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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.

Read the 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.

03

Conditions studied

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

Keywords

  • neuro-embolization
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are undergoing endovascular intervention will be enrolled into the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceTransradial 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).

06

What researchers measure

Primary outcomes

  1. Feasibility of TRA Intervention

    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.

    Time frame: 1 month

Secondary outcomes

  1. Assess radial artery occlusion rates post procedure

    Reverse Barbue Test and ultrasound

    Time frame: 1 month

  2. Demographics

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

    Time frame: 1 month

07

Study locations

1 site
  • University Hospital
    Newark, New Jersey 07101, United States
08

References and documents

Publications

  • 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. PubMed 19081409 ↗
  • 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. PubMed 20965460 ↗
  • 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. PubMed 23354100 ↗
  • 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. PubMed 29665617 ↗
  • 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. PubMed 29311120 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Aggregate data will be presented

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Sep 2022, 23 months.

Of 181 non-industry observational studies under Brain Neoplasms, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 269. This study's 23 months is below that.

Counting every sponsor, half of 199 studies reached it within 82 months; a quarter within 41 and three quarters within 269.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2020
First posted
Sep 17, 2020
StartActual
Oct 1, 2020
Primary completionActual
Sep 15, 2022
CompletionActual
Oct 30, 2022
Last update
Dec 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04553549
Responsible party
Priyank Khandelwal, MD (Assistant Professor, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Sep 17, 2020
Start date
Oct 1, 2020
Primary completion
Sep 15, 2022
Completion
Oct 30, 2022
Last update
Dec 11, 2023

Study contacts

Priyank Khandelwal, MD
principal investigator · Rutgers University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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