Angiography, Digital SubtractionRCTNCT07696936
Robot-Assisted vs Manual Transradial Cerebral Angiography
A study testing Robot-assisted angiographic system in people with Angiography, Digital Subtraction and Robot-assisted Therapy, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This is a prospective, randomized controlled clinical trial designed to compare the safety and effectiveness of robot-assisted transradial cerebral angiography versus manual operation performed by experienced neurosurgeons. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angiography, Digital Subtraction, Robot-assisted Therapy
- What is being tested?
- Robot-assisted angiographic system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 80 years, regardless of gender;
- Stable vital signs, eligible for routine cerebral digital subtraction angiography (DSA);
- Suspected intracranial vascular lesions (stenosis, aneurysm, malformation, etc.) by computed tomography angiography (CTA)/magnetic resonance angiography (MRA) requiring further confirmation, or need to clarify the blood supply of intracranial space-occupying lesions/qualification of tumors;
- Positive Allen's test;
- Ultrasound shows radial artery diameter >2.0 mm, or <2.0 mm but still eligible for transradial angiography as evaluated by senior physicians.
Who cannot join
- Patients with contrast medium allergy;
- Patients with acute hemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, and patients with unstable acute stroke;
- Patients with severe vascular malformation/stenosis/occlusion, severe hepatic and renal insufficiency, severe hypertension/hypotension, severe infection, coagulation dysfunction, severe cardio-cerebro-pulmonary diseases, congestive heart failure;
- Pregnant/lactating women and women planning to become pregnant within 1 year;
- Patients clinically ineligible for cerebral DSA;
- Patients with fear of interventional robots and refusal of robot-assisted angiography.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiangyu Meng, PhD contact
China1 site, 1 recruiting
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xiangyu Dr.Meng, Doctor, +86-18810676276, Mengyu629@126.com
About this study
Official title: Comparison of Safety and Efficacy Between Robot-Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: A Prospective Randomized Controlled Trial
This is a prospective, randomized controlled clinical trial designed to compare the safety and effectiveness of robot-assisted transradial cerebral angiography versus manual operation performed by experienced neurosurgeons. The study will be conducted at the Department of Neurosurgery, The First Hospital of Hebei Medical University, with a total sample size of 156 participants.
Why is this study being done? Cerebral angiography is a key diagnostic procedure for cerebrovascular diseases, such as stroke, aneurysm, and vascular malformation. Traditionally, it is performed manually by interventional physicians, who are exposed to significant radiation during the procedure. Robot-assisted technology offers a potential solution by allowing doctors to operate from a separate, shielded room, which could greatly reduce occupational radiation exposure. This study aims to verify whether robot-assisted transradial cerebral angiography is non-inferior to the standard manual approach in terms of safety and clinical success, while providing additional benefits for both patients and physicians.
Read more
Who can participate?
We plan to enroll 156 adult patients (aged 18-80 years) who meet the following criteria:
Stable vital signs and eligible for routine cerebral angiography Suspected intracranial vascular lesions or need for evaluation of intracranial mass blood supply, confirmed by CTA/MRA Positive Allen's test and adequate radial artery diameter (assessed by ultrasound) Able to provide informed consent Patients will be excluded if they have contrast allergy, require emergency angiography, have severe organ dysfunction, are pregnant or breastfeeding, or refuse robot-assisted procedures.
What will happen during the study?
After providing informed consent, eligible participants will be randomly assigned to one of two groups in a 1:1 ratio:
Robot-assisted group: Cerebral angiography will be performed using a dedicated cerebrovascular interventional robot system, with the physician operating from a remote, radiation-free room.
Manual control group: Cerebral angiography will be performed by experienced neurosurgeons using the standard manual technique.
During the procedure, researchers will record key metrics including:
Technical and clinical success rates of angiography Total procedure time and radiation exposure for both patients and physicians Incidence of perioperative and postoperative complications (e.g., vascular injury, hematoma, contrast reaction) Participants will be followed until hospital discharge or their next scheduled interventional treatment, during which all adverse events and complications will be carefully documented.
What are the potential risks and benefits?
Potential benefits:
Participants will receive high-standard cerebral angiography care, either via robot-assisted or manual operation, both of which are clinically approved methods.
The study results may help establish robot-assisted technology as a safe, effective alternative for cerebrovascular diagnosis, which could reduce physician radiation exposure and improve procedural precision in the future.
Potential risks:
Standard risks associated with cerebral angiography, including contrast allergy, vascular spasm, dissection, or puncture-site hematoma.
Very low risk of device-related complications, such as unintended robot movement, which will be mitigated by strict operator training and safety protocols.
How will the data be analyzed? All data will be analyzed using SAS 9.4 or later software. The primary analysis will use a non-inferiority design to compare the clinical success rate between the two groups. Secondary analyses will compare complication rates, radiation exposure, procedure duration, patient comfort, and surgeon satisfaction. All statistical tests will be two-sided, with a p-value ≤ 0.05 considered statistically significant.
This study is designed to provide robust evidence on the safety and efficacy of robot-assisted transradial cerebral angiography, with the ultimate goal of advancing minimally invasive cerebrovascular care and protecting healthcare workers from occupational radiation hazards.
Read the detailed description
- Basic Study Information Study Title: Comparison of Safety and Efficacy between Robot-Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: A Prospective Randomized Controlled Trial Sponsor: The First Hospital of Hebei Medical University, Hebei Hospital of Xuanwu Hospital Performing Department: Department of Neurosurgery, The First Hospital of Hebei Medical University Principal Investigator: Li Conghui Study Design: Single-center, prospective, non-inferiority, open-label randomized controlled trial with independent blinded endpoint adjudication and blinded data analysts
- Study Objectives To systematically investigate the safety and efficacy of high-precision robot-assisted system for cerebral angiography via transradial approach, evaluate its operational accuracy, expand the application scenarios of cerebrovascular interventional surgical robots, provide precise and safe technical support for the diagnosis and treatment of cerebrovascular diseases, and promote the innovation and development of relevant high and new technologies.
- Study Population Inclusion Criteria Aged 18 to 80 years, regardless of gender; Stable vital signs, eligible for routine cerebral digital subtraction angiography (DSA); Suspected intracranial vascular lesions (stenosis, aneurysm, malformation, etc.) by computed tomography angiography (CTA)/magnetic resonance angiography (MRA) requiring further confirmation, or need to clarify the blood supply of intracranial space-occupying lesions/qualification of tumors; Positive Allen's test; Ultrasound shows radial artery diameter >2.0 mm, or <2.0 mm but still eligible for transradial angiography as evaluated by senior physicians. Exclusion Criteria Patients with contrast medium allergy; Patients with acute hemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, and patients with unstable acute stroke; Patients with severe vascular malformation/stenosis/occlusion, severe hepatic and renal insufficiency, severe hypertension/hypotension, severe infection, coagulation dysfunction, severe cardio-cerebro-pulmonary diseases, congestive heart failure; Pregnant/lactating women and women planning to become pregnant within 1 year; Patients clinically ineligible for cerebral DSA; Patients with fear of interventional robots and refusal of robot-assisted angiography. Sample Size: A total of 156 cases, 78 cases in the experimental group (robot-assisted group) and 78 cases in the control group (manual group) (74 cases per group in basic calculation, expanded considering a 5% loss rate).
- Interventions Experimental Group: Robot-assisted transradial cerebral DSA (applying the "Cerebrovascular Interventional Surgery Assisted Operating System" developed by Yidu Medical, with full-process remote compartment operation); Control Group: Manual transradial cerebral DSA performed by experienced neurosurgeons.
- Randomization and Blinding Randomization: Block randomization mode, led by an independent third party (Randomization Management Group, non-surgical/evaluation staff); clinical medical staff are only responsible for screening, informed consent and surgery implementation. After assigning a unique number to enrolled patients, the clinical research coordinator (CRC) completes random grouping, and grouping information is confidentially filed. Blinding: Blinded outcome assessors (CRF recorders not involved in surgery), blinded data analysts (groups coded as Group A/B during statistical analysis, decrypted after analysis); an emergency unblinding mechanism is established, unblinding is allowed in case of serious adverse events, and data are marked separately after unblinding.
- Study Endpoints Primary Endpoints Technical success rate of intracranial major vascular angiography: Accurate positioning of target vessels for angiography with qualified image quality; Clinical success rate of intracranial major vascular angiography: Completion of angiography for at least 4 supra-aortic major arteries (bilateral common carotid arteries + bilateral subclavian arteries). Secondary Endpoints Incidence of various perioperative and postoperative complications; Total radiation dose received by patients and primary surgeons; Total duration of the entire angiography process, robot installation time, and single angiography duration of each intracranial vessel; Targeting accuracy of the operation; Patient satisfaction and comfort; Surgeon learning curve; Cost-effectiveness analysis.
- Study Risks and Benefits Benefits Expand the application scope of robots and improve patients' surgical comfort; Clarify the accuracy and reliability of robot-assisted transradial angiography, achieving a success rate comparable to manual angiography; Reduce occupational radiation damage to physicians and realize robot-assisted remote compartment "zero-radiation" operation. Risks Routine risks of cerebral DSA: Cardiac events, cerebrovascular events, adverse reactions to contrast medium, vascular rupture/thrombosis/spasm/dissection, puncture site hematoma/pseudoaneurysm, etc.; Very low probability of device-related risk: Vascular injury caused by unintended movement of the robot.
- Follow-up Plan Pre-enrollment Visit: Demographic statistics, recording of concomitant medications, safety examinations (pregnancy test, vital signs, routine blood test, hepatic and renal function, four coagulation tests, electrocardiogram), verification of inclusion and exclusion criteria; Intraoperative Visit: Recording of angiography success rate, each time node, total duration, adverse events, concomitant medications; Postoperative Visit: Follow-up until patient discharge or before the next cerebrovascular interventional treatment, recording of perioperative and postoperative complications, adverse events, concomitant medications.
- Statistical Analysis Software: SAS version 9.4 and above; Test Criterion: Two-sided test, P ≤ 0.05 is considered statistically significant; Analysis Populations: Full Analysis Set (per intention-to-treat principle), Per-Protocol Set, Safety Analysis Set; Analysis Methods: Quantitative indicators are expressed as mean ± standard deviation/median (interquartile range), analyzed by t-test/Mann-Whitney U test; categorical indicators are expressed as number/percentage, analyzed by Chi-square test/Fisher's exact test; interim analysis (safety rules) and subgroup analysis (complex anatomy, surgeon experience) are set; sensitivity analysis for missing data is performed by worst/best-case scenario method and multiple imputation method.
- Trial Termination Criteria Occurrence of serious safety events; Major errors in the study protocol/serious deviations in implementation, making it impossible to evaluate efficacy; Poor efficacy/defects of the study device with no clinical value; Termination requested by the sponsor; Trial revoked by the administrative department.
- Being tested
- Robot-assisted angiographic system, Manual controlled transradial artery angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted angiographic systemDevice
Cerebral angiography will be performed using a dedicated cerebrovascular interventional robot system, with the physician operating from a remote, radiation-free room.
Manual controlled transradial artery angiographyProcedure or surgery
Cerebral angiography will be performed by experienced neurosurgeons using the standard manual technique.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted transradial angiography | Experimental | Cerebral angiography will be performed using a dedicated cerebrovascular interventional robot system, with the physician operating from a remote, radiation-free room. Receives: Device: Robot-assisted angiographic system |
| Manual control transradial angiography | Active comparator | Cerebral angiography will be performed by experienced neurosurgeons using the standard manual technique. Receives: Procedure: Manual controlled transradial artery angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Technical success rate of intracranial major vascular angiography: Accurate positioning of target vessels for angiography with qualified image quality;
Measured: Perioperative/Periprocedural
Clinical success rate
Clinical success rate of intracranial major vascular angiography: Completion of angiography for at least 4 supra-aortic major arteries (bilateral common carotid arteries + bilateral subclavian arteries).
Measured: Perioperative/Periprocedural
Secondary outcomes (4)
perioperative and postoperative complications
Incidence of various perioperative and postoperative complications;
Measured: Perioperative/Periprocedural
Radiation dose
Total radiation dose received by patients and primary surgeons;
Measured: Perioperative/Periprocedural
Time Period
Total duration of the entire angiography process, robot installation time, and single angiography duration of each intracranial vessel;
Measured: Perioperative/Periprocedural
Follow-up until patient discharge
Follow-up until patient discharge or before the next cerebrovascular interventional treatment, recording of perioperative and postoperative complications, adverse events, concomitant medications.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Nov 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angiography, Digital SubtractionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conghui Li, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696936
- Sponsor's protocol ID
- 2026-003
- Acronym
- RCT
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy Between Robot-Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07696936
- Acronym / sponsor ID
- RCT / 2026-003
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Jul 2026 (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 is a prospective, randomized controlled clinical trial designed to compare the safety and effectiveness of robot-assisted transradial cerebral angiography versus manual operation performed by experienced neurosurgeons. The study will be conducted at the Department of Neurosurgery, The First Hospital of Hebei Medical University, with a total sample size of 156 participants.
Why is this study being done? Cerebral angiography is a key diagnostic procedure for cerebrovascular diseases, such as stroke, aneurysm, and vascular malformation. Traditionally, it is performed manually by interventional physicians, who are exposed to significant radiation during the procedure. Robot-assisted technology offers a potential solution by allowing doctors to operate from a separate, shielded room, which could greatly reduce occupational radiation exposure. This study aims to verify whether robot-assisted transradial cerebral angiography is non-inferior to the standard manual approach in terms of safety and clinical success, while providing additional benefits for both patients and physicians.
Who can participate?
We plan to enroll 156 adult patients (aged 18-80 years) who meet the following criteria:
Stable vital signs and eligible for routine cerebral angiography Suspected intracranial vascular lesions or need for evaluation of intracranial mass blood supply, confirmed by CTA/MRA Positive Allen's test and adequate radial artery diameter (assessed by ultrasound) Able to provide informed consent Patients will be excluded if they have contrast allergy, require emergency angiography, have severe organ dysfunction, are pregnant or breastfeeding, or refuse robot-assisted procedures.
What will happen during the study?
After providing informed consent, eligible participants will be randomly assigned to one of two groups in a 1:1 ratio:
Robot-assisted group: Cerebral angiography will be performed using a dedicated cerebrovascular interventional robot system, with the physician operating from a remote, radiation-free room.
Manual control group: Cerebral angiography will be performed by experienced neurosurgeons using the standard manual technique.
During the procedure, researchers will record key metrics including:
Technical and clinical success rates of angiography Total procedure time and radiation exposure for both patients and physicians Incidence of perioperative and postoperative complications (e.g., vascular injury, hematoma, contrast reaction) Participants will be followed until hospital discharge or their next scheduled interventional treatment, during which all adverse events and complications will be carefully documented.
What are the potential risks and benefits?
Potential benefits:
Participants will receive high-standard cerebral angiography care, either via robot-assisted or manual operation, both of which are clinically approved methods.
The study results may help establish robot-assisted technology as a safe, effective alternative for cerebrovascular diagnosis, which could reduce physician radiation exposure and improve procedural precision in the future.
Potential risks:
Standard risks associated with cerebral angiography, including contrast allergy, vascular spasm, dissection, or puncture-site hematoma.
Very low risk of device-related complications, such as unintended robot movement, which will be mitigated by strict operator training and safety protocols.
How will the data be analyzed? All data will be analyzed using SAS 9.4 or later software. The primary analysis will use a non-inferiority design to compare the clinical success rate between the two groups. Secondary analyses will compare complication rates, radiation exposure, procedure duration, patient comfort, and surgeon satisfaction. All statistical tests will be two-sided, with a p-value ≤ 0.05 considered statistically significant.
This study is designed to provide robust evidence on the safety and efficacy of robot-assisted transradial cerebral angiography, with the ultimate goal of advancing minimally invasive cerebrovascular care and protecting healthcare workers from occupational radiation hazards.
Detailed description
- Basic Study Information Study Title: Comparison of Safety and Efficacy between Robot-Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: A Prospective Randomized Controlled Trial Sponsor: The First Hospital of Hebei Medical University, Hebei Hospital of Xuanwu Hospital Performing Department: Department of Neurosurgery, The First Hospital of Hebei Medical University Principal Investigator: Li Conghui Study Design: Single-center, prospective, non-inferiority, open-label randomized controlled trial with independent blinded endpoint adjudication and blinded data analysts
- Study Objectives To systematically investigate the safety and efficacy of high-precision robot-assisted system for cerebral angiography via transradial approach, evaluate its operational accuracy, expand the application scenarios of cerebrovascular interventional surgical robots, provide precise and safe technical support for the diagnosis and treatment of cerebrovascular diseases, and promote the innovation and development of relevant high and new technologies.
- Study Population Inclusion Criteria Aged 18 to 80 years, regardless of gender; Stable vital signs, eligible for routine cerebral digital subtraction angiography (DSA); Suspected intracranial vascular lesions (stenosis, aneurysm, malformation, etc.) by computed tomography angiography (CTA)/magnetic resonance angiography (MRA) requiring further confirmation, or need to clarify the blood supply of intracranial space-occupying lesions/qualification of tumors; Positive Allen's test; Ultrasound shows radial artery diameter >2.0 mm, or <2.0 mm but still eligible for transradial angiography as evaluated by senior physicians. Exclusion Criteria Patients with contrast medium allergy; Patients with acute hemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, and patients with unstable acute stroke; Patients with severe vascular malformation/stenosis/occlusion, severe hepatic and renal insufficiency, severe hypertension/hypotension, severe infection, coagulation dysfunction, severe cardio-cerebro-pulmonary diseases, congestive heart failure; Pregnant/lactating women and women planning to become pregnant within 1 year; Patients clinically ineligible for cerebral DSA; Patients with fear of interventional robots and refusal of robot-assisted angiography. Sample Size: A total of 156 cases, 78 cases in the experimental group (robot-assisted group) and 78 cases in the control group (manual group) (74 cases per group in basic calculation, expanded considering a 5% loss rate).
- Interventions Experimental Group: Robot-assisted transradial cerebral DSA (applying the "Cerebrovascular Interventional Surgery Assisted Operating System" developed by Yidu Medical, with full-process remote compartment operation); Control Group: Manual transradial cerebral DSA performed by experienced neurosurgeons.
- Randomization and Blinding Randomization: Block randomization mode, led by an independent third party (Randomization Management Group, non-surgical/evaluation staff); clinical medical staff are only responsible for screening, informed consent and surgery implementation. After assigning a unique number to enrolled patients, the clinical research coordinator (CRC) completes random grouping, and grouping information is confidentially filed. Blinding: Blinded outcome assessors (CRF recorders not involved in surgery), blinded data analysts (groups coded as Group A/B during statistical analysis, decrypted after analysis); an emergency unblinding mechanism is established, unblinding is allowed in case of serious adverse events, and data are marked separately after unblinding.
- Study Endpoints Primary Endpoints Technical success rate of intracranial major vascular angiography: Accurate positioning of target vessels for angiography with qualified image quality; Clinical success rate of intracranial major vascular angiography: Completion of angiography for at least 4 supra-aortic major arteries (bilateral common carotid arteries + bilateral subclavian arteries). Secondary Endpoints Incidence of various perioperative and postoperative complications; Total radiation dose received by patients and primary surgeons; Total duration of the entire angiography process, robot installation time, and single angiography duration of each intracranial vessel; Targeting accuracy of the operation; Patient satisfaction and comfort; Surgeon learning curve; Cost-effectiveness analysis.
- Study Risks and Benefits Benefits Expand the application scope of robots and improve patients' surgical comfort; Clarify the accuracy and reliability of robot-assisted transradial angiography, achieving a success rate comparable to manual angiography; Reduce occupational radiation damage to physicians and realize robot-assisted remote compartment "zero-radiation" operation. Risks Routine risks of cerebral DSA: Cardiac events, cerebrovascular events, adverse reactions to contrast medium, vascular rupture/thrombosis/spasm/dissection, puncture site hematoma/pseudoaneurysm, etc.; Very low probability of device-related risk: Vascular injury caused by unintended movement of the robot.
- Follow-up Plan Pre-enrollment Visit: Demographic statistics, recording of concomitant medications, safety examinations (pregnancy test, vital signs, routine blood test, hepatic and renal function, four coagulation tests, electrocardiogram), verification of inclusion and exclusion criteria; Intraoperative Visit: Recording of angiography success rate, each time node, total duration, adverse events, concomitant medications; Postoperative Visit: Follow-up until patient discharge or before the next cerebrovascular interventional treatment, recording of perioperative and postoperative complications, adverse events, concomitant medications.
- Statistical Analysis Software: SAS version 9.4 and above; Test Criterion: Two-sided test, P ≤ 0.05 is considered statistically significant; Analysis Populations: Full Analysis Set (per intention-to-treat principle), Per-Protocol Set, Safety Analysis Set; Analysis Methods: Quantitative indicators are expressed as mean ± standard deviation/median (interquartile range), analyzed by t-test/Mann-Whitney U test; categorical indicators are expressed as number/percentage, analyzed by Chi-square test/Fisher's exact test; interim analysis (safety rules) and subgroup analysis (complex anatomy, surgeon experience) are set; sensitivity analysis for missing data is performed by worst/best-case scenario method and multiple imputation method.
- Trial Termination Criteria Occurrence of serious safety events; Major errors in the study protocol/serious deviations in implementation, making it impossible to evaluate efficacy; Poor efficacy/defects of the study device with no clinical value; Termination requested by the sponsor; Trial revoked by the administrative department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted transradial angiography | Experimental | Device: Robot-assisted angiographic systemCerebral angiography will be performed using a dedicated cerebrovascular interventional robot system, with the physician operating from a remote, radiation-free room. |
| Manual control transradial angiography | Active comparator | Procedure: Manual controlled transradial artery angiographyCerebral angiography will be performed by experienced neurosurgeons using the standard manual technique. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 80 years, regardless of gender;
- Stable vital signs, eligible for routine cerebral digital subtraction angiography (DSA);
- Suspected intracranial vascular lesions (stenosis, aneurysm, malformation, etc.) by computed tomography angiography (CTA)/magnetic resonance angiography (MRA) requiring further confirmation, or need to clarify the blood supply of intracranial space-occupying lesions/qualification of tumors;
- Positive Allen's test;
- Ultrasound shows radial artery diameter >2.0 mm, or <2.0 mm but still eligible for transradial angiography as evaluated by senior physicians.
Key exclusion criteria (6 listed)
- Patients with contrast medium allergy;
- Patients with acute hemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, and patients with unstable acute stroke;
- Patients with severe vascular malformation/stenosis/occlusion, severe hepatic and renal insufficiency, severe hypertension/hypotension, severe infection, coagulation dysfunction, severe cardio-cerebro-pulmonary diseases, congestive heart failure;
- Pregnant/lactating women and women planning to become pregnant within 1 year;
- Patients clinically ineligible for cerebral DSA;
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 |
|---|---|---|
| Robot-assisted angiographic systemCerebral angiography will be performed using a dedicated cerebrovascular interventional robot system, with the physician operating from a remote, radiation-free room. | Device | Robot-assisted transradial angiography |
| Manual controlled transradial artery angiographyCerebral angiography will be performed by experienced neurosurgeons using the standard manual technique. | Procedure or surgery | Manual control transradial angiography |
Primary outcome
Technical success rate
Time frame: Perioperative/Periprocedural
Technical success rate of intracranial major vascular angiography: Accurate positioning of target vessels for angiography with qualified image quality;
Clinical success rate
Time frame: Perioperative/Periprocedural
Clinical success rate of intracranial major vascular angiography: Completion of angiography for at least 4 supra-aortic major arteries (bilateral common carotid arteries + bilateral subclavian arteries).
4 secondary outcomes
perioperative and postoperative complications
Time frame: Perioperative/Periprocedural
Radiation dose
Time frame: Perioperative/Periprocedural
Time Period
Time frame: Perioperative/Periprocedural
Follow-up until patient discharge
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- 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.
Xiangyu Meng, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted angiographic system in people with Angiography, Digital Subtraction and Robot-assisted Therapy, run by The First Hospital of Hebei 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Conghui Li, PhD (+8618633889708, 13363880072@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: Perioperative/Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.