Transradial Access for Ruptured Intracranial Aneurysms Embolization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-05-31

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.

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Detailed Description

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Conditions

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Transradial Access

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

transradial access

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Transfemoral access

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No