Transradial Access for Ruptured Intracranial Aneurysms Embolization (TRA-RIA)
May 7, 2023 updated by: Lu Hua, The First Affiliated Hospital with Nanjing Medical University
Transradial Access for Ruptured Intracranial Aneurysms Embolization--A Multicentre, Randomised, Open-label,Non-inferiority Trial
The goal of this clinical trail is to compare the difference between transradial access (TRA) and transfemoral access(TFA) for ruptured intracranial aneurysms embolization.
The main question it aims to answer is: whether is TRA not inferior to TFA？ In the experimental group, the transradial access (TRA) was used, which was to puncture the radial artery and insert a radial sheath to establish a surgical pathway for embolization of the aneurysm; In the control group, transfemoral access (TFA) was used to embolize the aneurysms, which was to puncture the femoral artery and insert the femoral sheath to establish a surgical pathway for embolizing the aneurysms.The two groups of patients received an oral loading dose of aspirin (300mg) plus clopidogrel (300mg) on the day of surgery, while patients who were unable to take orally were given nasal feeding.
During the operation, systemic heparinization was performed with a starting dose of 75U/kg intravenous injection, and the injection was halved every 1h until 1000U.
After the operation, protamine neutralizing heparin (1mg protamine neutralizing 100U heparin) was used.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
242
Phase
- Not Applicable
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: Lei M Mao Lei
- Phone Number: 13057658078
- Email: 2165451550@qq.com
Study Contact Backup
- Name: Hua L Lu Hua
- Phone Number: 18761671021
- Email: luhua@njmu.edu.cn
Study Locations
-
-
-
Nanjing, China
- Jiangsu Province 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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The age is between 18 and 75 years old.
- Receiving interventional embolization treatment for intracranial aneurysms.
- CT scan of the skull shows subarachnoid hemorrhage, and CTA or DSA of the skull shows the presence of an intracranial aneurysm, and it is determined to be aneurysm-related subarachnoid hemorrhage after evaluation by a neurosurgical specialist.
- At least one side of the bilateral radial arteries can be used to establish surgical access.
- Evaluation of radial artery patency: Barbeau test type A-C .
- Hunt-Hess grade 1-3, Glasgow coma score ≥ 8.
- Agreed to participate in this study and willing to cooperate with follow-up. -
Exclusion Criteria:
- Preoperative upper limb ultrasound or DSA showed radial artery spasm and arteriovenous fistula.
- Artery CTA or DSA showed vascular anatomical abnormalities such as axillary artery occlusion, and acute angle between the left common carotid artery and the subclavian artery, which may affect the operation.
- The patient's condition is serious and may die or remain in a coma after surgery, as assessed by a specialist.
- Received radial or femoral artery puncture examination or treatment within 1 month.
- The patient refused to participate in the study or cooperate with follow-up.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transradial access
In this group, the transradial access (TRA) was used, which was to puncture the radial artery and insert a radial sheath to establish a surgical pathway for embolization of the aneurysm.
|
In this group, the transradial access (TRA) was used, which was to puncture the radial artery and insert a radial sheath to establish a surgical pathway for embolization of the aneurysm
|
|
Active Comparator: Transfemoral access
In this group, transfemoral access (TFA) was used to embolize the aneurysms, which was to puncture the femoral artery and insert the femoral sheath to establish a surgical pathway for embolizing the aneurysm.
|
In this group, transfemoral access (TFA) was used to embolize the aneurysms, which was to puncture the femoral artery and insert the femoral sheath to establish a surgical pathway for embolizing the aneurysm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The success rate of operation
Time Frame: during the procedure
|
The success rate of operation
|
during the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of ischemic events
Time Frame: immediately after the procedure
|
Incidence of ischemic events
|
immediately after the procedure
|
|
Incidence of hemorrhage events
Time Frame: immediately after the procedure
|
Incidence of hemorrhage events
|
immediately after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hua L Lu Hua, The First Affiliated Hospital with Nanjing Medical 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
- Chivot C, Bouzerar R, Yzet T. Transitioning to Transradial Access for Cerebral Aneurysm Embolization. AJNR Am J Neuroradiol. 2019 Nov;40(11):1947-1953. doi: 10.3174/ajnr.A6234. Epub 2019 Oct 3.
- Chen SH, Snelling BM, Shah SS, Sur S, Brunet MC, Starke RM, Yavagal DR, Osbun JW, Peterson EC. Transradial approach for flow diversion treatment of cerebral aneurysms: a multicenter study. J Neurointerv Surg. 2019 Aug;11(8):796-800. doi: 10.1136/neurintsurg-2018-014620. Epub 2019 Jan 22.
- Chiu AH. Is Transradial Access a Replacement Technique for Transfemoral Access in Neurointervention? AJNR Am J Neuroradiol. 2021 Mar;42(3):493-494. doi: 10.3174/ajnr.A6935. Epub 2021 Jan 14. No abstract available.
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 (Anticipated)
May 10, 2023
Primary Completion (Anticipated)
April 30, 2024
Study Completion (Anticipated)
May 31, 2024
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
May 7, 2023
First Posted (Actual)
May 9, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 7, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRA-RIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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