Cerebral AngiographyNCT05401669
Transradial Versus Transfemoral Access for Cerebral Angiography
A study testing Trans-radial access and Trans-femoral access in people with Cerebral Angiography, run by Huashan Hospital at 1 site in China.
Trial summary
This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Angiography
- What is being tested?
- Trans-radial access and Trans-femoral access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 20 Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old;
- Scheduled to undergo diagnostic cerebral angiography;
- Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography;
- Modified Rankin Scale (mRS) score ≤2;
- Provided written informed consent.
Who cannot join
- Severe stenosis of the radial, brachial, subclavian, brachiocephalic, iliac or common femoral arteries, or any significant vascular disease (such as aortic aneurysm, etc.) that may obstruct guidewire passage;
- Arteriovenous fistula for hemodialysis present in the right upper limb;
- Planned interventional surgery within 24 hours of the initial study angiography;
- Requirement for cerebral angiography in an emergency department;
- Use of general anesthesia;
- Any contraindication to cerebral angiography, such as allergy or intolerance to the contrast media, uncorrected severe coagulation disorders, arterial dissection in the target vessel, puncture site infection, or renal insufficiency (Creatinine [Gr] > 3 times of the upper limit of normal [ULN]), etc.;
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- Women who are pregnant or planning to become pregnant within 1 year;
- Participation in another clinical trial;
- Any other condition deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shangai, 200000
Heng Yang, PhD,MD, 13162909815, yangheng901109@163.com
About this study
This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography.
Read the detailed description
TFA is traditional approach for diagnostic cerebral angiography, which has several limitations and complications including pain and discomfort, retroperitoneal hemorrhage, pulmonary embolism and increased admissions. Transradial coronary angiography has demonstrated preponderance to circumvent this limitations and complications. However, this has not been studied in cerebral angiography. So, the purpose of this study is to assess and compare the feasibility, safety and success of TRA versus TFA for diagnostic cerebral angiography.
- Conditions
- Cerebral Angiography
- Being tested
- Trans-radial access, Trans-femoral access
- Keywords
- Cerebral Angiography, Transfemoral Arterial access, Transradial Arterial access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-radial accessProcedure or surgery
Cerebral angiography performed by trans-radial access
Trans-femoral accessProcedure or surgery
Cerebral angiography performed by trans-femoral access
| Study group | Role | What they receive |
|---|---|---|
| Trans-radial artery access | Experimental | Not described Receives: Procedure: Trans-radial access |
| Trans-femoral Artery access | Active comparator | Not described Receives: Procedure: Trans-femoral access |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of successful diagnostic cerebral angiography
the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements
Measured: 24 hours
Secondary outcomes (5)
the rate of successful accurate diagnosis
Measured: 24 hours
the duration of angiography
time taken to do the full procedure
Measured: During procedure
the duration of fluoroscopy
Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography
Measured: During procedure
the bedridden time
Measured: 24 hours
the Visual Analogue Scale (VAS) score
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start15 Sep 2023
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral AngiographyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 748 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxiang Gu, Huashan Hospital
- Investigators
- Yuxiang Gu, PhD,MD, Study chair, department of Neurosurgery, Huashan Hospital,Fudan UniversityWei Ni, PhD,MD, Study director, department of Neurosurgery, Huashan Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401669
- Sponsor's protocol ID
- 2021Y9308
- Status last verified
- Aug 2024
- First submitted
- 23 May 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ni W, Yang H, Su J, Peng Y, Wang D, Lin Z, Sun J, Chen X, Wang J, Li Y, Wang J, Wan S, Ye X, Zhang Q, Wang D, Gao C, Jiang H, Gao X, Zhang Y, Han B, Cao J, Zhu X, Zhou S, Zeng Y, Chen F, Lin Y, Ba H, Chen X, Liu X, Hao J, Sun Z, Li M, Wang M, Xie D, Zhuang Z, Shi L, Zhou L, Tang H, Chen D, Anderson CS, Kang D, Gu Y; TRACE Investigators. Transradial vs Transfemoral Access for Cerebral Angiography: A Randomized Noninferiority Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261929. doi: 10.1001/jamanetworkopen.2026.1929.
PubMed 41854613
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial Versus Transfemoral Access for Cerebral Angiography
- ClinicalTrials.gov ID
- NCT05401669
- Acronym / sponsor ID
- 2021Y9308
- Conditions
- Cerebral Angiography
- Keywords
- Cerebral Angiography, Transfemoral Arterial access, Transradial Arterial access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 748 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 2 Jun 2022 (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.
This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography.
Detailed description
TFA is traditional approach for diagnostic cerebral angiography, which has several limitations and complications including pain and discomfort, retroperitoneal hemorrhage, pulmonary embolism and increased admissions. Transradial coronary angiography has demonstrated preponderance to circumvent this limitations and complications. However, this has not been studied in cerebral angiography. So, the purpose of this study is to assess and compare the feasibility, safety and success of TRA versus TFA for diagnostic cerebral angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-radial artery access | Experimental | Procedure: Trans-radial access |
| Trans-femoral Artery access | Active comparator | Procedure: Trans-femoral access |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years old;
- Scheduled to undergo diagnostic cerebral angiography;
- Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography;
- Modified Rankin Scale (mRS) score ≤2;
- Provided written informed consent.
Key exclusion criteria (9 listed)
- Severe stenosis of the radial, brachial, subclavian, brachiocephalic, iliac or common femoral arteries, or any significant vascular disease (such as aortic aneurysm, etc.) that may obstruct guidewire passage;
- Arteriovenous fistula for hemodialysis present in the right upper limb;
- Planned interventional surgery within 24 hours of the initial study angiography;
- Requirement for cerebral angiography in an emergency department;
- Use of general anesthesia;
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 |
|---|---|---|
| Trans-radial accessCerebral angiography performed by trans-radial access | Procedure or surgery | Trans-radial artery access |
| Trans-femoral accessCerebral angiography performed by trans-femoral access | Procedure or surgery | Trans-femoral Artery access |
Primary outcome
the rate of successful diagnostic cerebral angiography
Time frame: 24 hours
the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements
5 secondary outcomes
the rate of successful accurate diagnosis
Time frame: 24 hours
the duration of angiography
Time frame: During procedure
the duration of fluoroscopy
Time frame: During procedure
the bedridden time
Time frame: 24 hours
the Visual Analogue Scale (VAS) score
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Derived from this study: PubMed 41854613Ni W, Yang H, Su J, Peng Y, Wang D, Lin Z, Sun J, Chen X, Wang J, Li Y, Wang J, Wan S, Ye X, Zhang Q, Wang D, Gao C, Jiang H, Gao X, Zhang Y, Han B, Cao J, Zhu X, Zhou S, Zeng Y, Chen F, Lin Y, Ba H, Chen X, Liu X, Hao J, Sun Z, Li M, Wang M, Xie D, Zhuang Z, Shi L, Zhou L, Tang H, Chen D, Anderson CS, Kang D, Gu Y; TRACE Investigators. Transradial vs Transfemoral Access for Cerebral Angiography: A Randomized Noninferiority Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261929. doi: 10.1001/jamanetworkopen.2026.1929.
- 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.
Yuxiang Gu, PhD,MD study chair
department of Neurosurgery, Huashan Hospital,Fudan University
Wei Ni, PhD,MD study director
department of Neurosurgery, Huashan Hospital,Fudan 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 Trans-radial access and Trans-femoral access in people with Cerebral Angiography, run by Huashan Hospital 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 5 inclusion and 9 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 4 Sep 2024. 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 Heng Yang, PhD, MD (13162909815, yangheng9011090@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of successful diagnostic cerebral angiography (time frame: 24 hours). 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 NCT05401669, which also lists 1 linked publication.
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 4 Sep 2024.