Transradial Access for Ruptured Intracranial Aneurysms Embolization

Study Overview
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Brief Summary
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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.

Official Title
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Transradial Access for Ruptured Intracranial Aneurysms Embolization--A Multicentre, Randomised, Open-label,Non-inferiority Trial

Conditions
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Transradial Access

Intervention / Treatment
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* Procedure: transradial access
* Procedure: Transfemoral access


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transradial access<br>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. | Procedure: transradial access<br>* 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<br>|
| Active Comparator: Transfemoral access<br>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. | Procedure: Transfemoral access<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of operation | The success rate of operation | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ischemic events | Incidence of ischemic events | immediately after the procedure | 
| Incidence of hemorrhage events | Incidence of hemorrhage events | immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transradial access, ruptured intracranial aneurysms, intervention