Transradial AccessTRA-RIANCT05851274
Transradial Access for Ruptured Intracranial Aneurysms Embolization
A study testing transradial access and Transfemoral access in people with Transradial Access, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transradial Access
- What is being tested?
- transradial access and Transfemoral access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transradial Access for Ruptured Intracranial Aneurysms Embolization--A Multicentre, Randomised, Open-label,Non-inferiority Trial
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
- Being tested
- transradial access, Transfemoral access
- Keywords
- transradial access, ruptured intracranial aneurysms, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transradial accessProcedure or surgery
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 accessProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Transfemoral access |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of operation
The success rate of operation
Measured: during the procedure
Secondary outcomes (2)
Incidence of ischemic events
Incidence of ischemic events
Measured: immediately after the procedure
Incidence of hemorrhage events
Incidence of hemorrhage events
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start10 May 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transradial AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Hua, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Hua L Lu Hua, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851274
- Sponsor's protocol ID
- TRA-RIA
- Acronym
- TRA-RIA
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31582386Chen 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.
PubMed 30670622Chiu 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.
PubMed 33446496
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial Access for Ruptured Intracranial Aneurysms Embolization--A Multicentre, Randomised, Open-label,Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05851274
- Acronym / sponsor ID
- TRA-RIA / TRA-RIA
- Conditions
- Transradial Access
- Keywords
- transradial access, ruptured intracranial aneurysms, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transradial access | Experimental | Procedure: transradial accessIn 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 | Active comparator | Procedure: Transfemoral accessIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 .
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transradial accessIn 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 or surgery | Transradial access |
| Transfemoral accessIn 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 or surgery | Transfemoral access |
Primary outcome
The success rate of operation
Time frame: during the procedure
The success rate of operation
2 secondary outcomes
Incidence of ischemic events
Time frame: immediately after the procedure
Incidence of hemorrhage events
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Results publication: PubMed 31582386Chivot 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.
- Results publication: PubMed 30670622Chen 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.
- Results publication: PubMed 33446496Chiu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua L Lu Hua principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transradial access and Transfemoral access in people with Transradial Access, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei M Mao Lei (13057658078, 2165451550@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of operation (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851274, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.