Clinical trial NCT05851274: Transradial Access for Ruptured Intracranial Aneurysms Embolization
Official title: Transradial Access for Ruptured Intracranial Aneurysms Embolization--A Multicentre, Randomised, Open-label,Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transradial Access
Keywords: transradial access
ruptured intracranial aneurysms
intervention
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. The age is between 18 and 75 years old.
2. Receiving interventional embolization treatment for intracranial aneurysms.
3. 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.
4. At least one side of the bilateral radial arteries can be used to establish surgical access.
5. Evaluation of radial artery patency: Barbeau test type A-C .
6. Hunt-Hess grade 1-3, Glasgow coma score ≥ 8.
7. Agreed to participate in this study and willing to cooperate with follow-up. -

Exclusion Criteria:

1. Preoperative upper limb ultrasound or DSA showed radial artery spasm and arteriovenous fistula.
2. 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.
3. The patient's condition is serious and may die or remain in a coma after surgery, as assessed by a specialist.
4. Received radial or femoral artery puncture examination or treatment within 1 month.
5. The patient refused to participate in the study or cooperate with follow-up.

Primary outcomes:
measure: The success rate of operation
timeFrame: during the procedure
Secondary outcomes:
measure: Incidence of ischemic events
timeFrame: immediately after the procedure
measure: Incidence of hemorrhage events
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Hua L Lu Hua
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.