TRA-RIA: Transradial Access for Ruptured Intracranial Aneurysms Embolization

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05851274

Collaborator

(none)

242

Enrollment

Location

Arms

12.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Transradial Access	Procedure: transradial access Procedure: Transfemoral access	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

242 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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.	Procedure: 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
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.	Procedure: 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.

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.

Procedure: 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

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.

Procedure: Transfemoral access

Outcome Measures

Primary Outcome Measures

The success rate of operation [during the procedure]
The success rate of operation

Secondary Outcome Measures

Incidence of ischemic events [immediately after the procedure]
Incidence of ischemic events
Incidence of hemorrhage events [immediately after the procedure]
Incidence of hemorrhage events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Province Hospital	Nanjing		China

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

Principal Investigator: Hua L Lu Hua, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lu Hua, Professor, The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT05851274

Other Study ID Numbers:

TRA-RIA

First Posted:

May 9, 2023

Last Update Posted:

May 9, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lu Hua, Professor, The First Affiliated Hospital with Nanjing Medical University

transradial access

ruptured intracranial aneurysms

intervention

Additional relevant MeSH terms:

Intracranial Aneurysm

Aneurysm

Study Results

No Results Posted as of May 9, 2023