Transradial Access for Ruptured Intracranial Aneurysms Embolization

NCT05851274 | Unknown DMC

• 1 other identifier: TRA-RIA
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Transradial Access

Keywords

transradial access; ruptured intracranial aneurysms; intervention

Outcome Measures

Primary Outcomes (1)

• The success rate of operation

  The success rate of operation

  during the procedure

Secondary Outcomes (2)

• Incidence of ischemic events

  immediately after the procedure

• Incidence of hemorrhage events

  immediately after the procedure

Study Arms (2)

Transradial access

EXPERIMENTAL

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

Transfemoral access

ACTIVE COMPARATOR

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

Interventions

transradial access PROCEDURE

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

Transradial access

Transfemoral access PROCEDURE

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.

Transfemoral access

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, China

Location

Related Publications (3)

• 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.

  PMID: 31582386 RESULT

• 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.

  PMID: 30670622 RESULT

• 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.

  PMID: 33446496 RESULT

Study Officials

• Hua L Lu Hua

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei M Mao Lei

CONTACT

13057658078; 2165451550@qq.com

Hua L Lu Hua

CONTACT

18761671021; luhua@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 9, 2023
• Study Start: May 10, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)