Back to resultsTransradial Access for Ruptured Intracranial Aneurysms Embolization (TRA-RIA)
Primary Purpose
Transradial Access
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transradial access
Transfemoral access
Sponsored by
About this trial
This is an interventional treatment trial for Transradial Access focused on measuring transradial access, ruptured intracranial aneurysms, intervention
Eligibility Criteria
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.
Sites / Locations
- Jiangsu Province Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transradial access
Transfemoral access
Arm Description
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, 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.
Outcomes
Primary Outcome Measures
The success rate of operation
The success rate of operation
Secondary Outcome Measures
Incidence of ischemic events
Incidence of ischemic events
Incidence of hemorrhage events
Incidence of hemorrhage events
Full Information
NCT ID
NCT05851274
First Posted
April 12, 2023
Last Updated
May 7, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05851274
Brief Title
Transradial Access for Ruptured Intracranial Aneurysms Embolization
Acronym
TRA-RIA
Official Title
Transradial Access for Ruptured Intracranial Aneurysms Embolization--A Multicentre, Randomised, Open-label,Non-inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 10, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transradial Access
Keywords
transradial access, ruptured intracranial aneurysms, intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 aneurysm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transradial access
Arm Type
Experimental
Arm Description
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.
Arm Title
Transfemoral access
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
transradial access
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Transfemoral access
Intervention Description
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.
Primary Outcome Measure Information:
Title
The success rate of operation
Description
The success rate of operation
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
Incidence of ischemic events
Description
Incidence of ischemic events
Time Frame
immediately after the procedure
Title
Incidence of hemorrhage events
Description
Incidence of hemorrhage events
Time Frame
immediately after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei M Mao Lei
Phone
13057658078
Email
2165451550@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua L Lu Hua
Phone
18761671021
Email
luhua@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua L Lu Hua
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31582386
Citation
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.
Results Reference
result
PubMed Identifier
30670622
Citation
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.
Results Reference
result
PubMed Identifier
33446496
Citation
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.
Results Reference
result
Learn more about this trial
Transradial Access for Ruptured Intracranial Aneurysms Embolization
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