Crerbral AngiographyNCT07182188

A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

A study testing Vascular Interventional Robotic System in people with Crerbral Angiography, run by Peking Union Medical College Hospital at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study aims to conduct a post-market, multicenter clinical trial utilizing an interventional robotic system for cerebral angiography. By comparing it with traditional angiography procedures, the study will systematically evaluate the efficacy and safety of robot-assisted angiography in real clinical settings. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Crerbral Angiography
What is being tested?: Vascular Interventional Robotic System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 660 participants
Where: 2 sitesChina
Study dates: 1 Sep 2024to 30 Apr 2027
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18 and 75 years;
Suspected vascular lesions in the head and neck, or other conditions involving head and neck vessels requiring whole-brain angiography for definitive diagnosis or to aid treatment decisions. Including but not limited to: intracranial aneurysms, arteriovenous malformations, cavernous malformations, arteriovenous fistulas, Moyamoya disease, Moyamoya syndrome, subarachnoid hemorrhage, symptomatic intracranial artery stenosis/occlusion, stenosis/occlusion of the carotid/subclavian/vertebral arteries, acute/ chronic subdural hematoma, etc;
American Society of Anesthesiologists (ASA) physical status classification I-III (no severe cardiopulmonary dysfunction);
Patients who voluntarily participate in this study and sign an informed consent form.

Who cannot join

Patients who are to undergo surgery at the same time as cerebral angiography;
Renal dysfunction (serum creatinine > 133 μmol/L or estimated glomerular filtration rate < 60 mL/min/1.73 m²);
Patients with known allergy to iodinated contrast media;
Coagulation disorders (prothrombin time >16s, activated partial thromboplastin time >45s, or platelet count <100×10⁹/L);
Severe infection, skin ulceration, or vascular anatomical abnormalities at the puncture site (e.g., bilateral femoral artery occlusion);
Pregnant or lactating women;

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Patients with severe cognitive impairment;
Patients with psychiatric disorders;
Patients unable to undergo head magnetic resonance imaging (MRI), e.g., those with metallic implants, claustrophobia, or other contraindications;
Patients with other severe advanced or terminal illnesses;
Patients currently participating in other clinical trials.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Post-Market Application Study and Efficacy/Safety Evaluation of a Vascular Interventional Robotic System for Cerebral Angiography: A Multicenter Randomized Controlled Trial

Read the detailed description

The ERASE trial is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded-endpoint study designed to enroll 660 patients. Patients with suspected head and neck vascular lesions requiring cerebral angiography for definitive diagnosis, who meet the ERASE trial's inclusion and exclusion criteria, will be considered for enrollment across seven comprehensive stroke centers in China.

Eligible patients will be randomized to one of two treatment groups: the robot-assisted group and the control group. Those assigned to the robot-assisted group will undergo cerebral angiography performed by physicians via the YDHB-NS01 Ver 2.0 robotic-assisted system, while those in the control group will undergo the procedure via manual techniques by physicians.

Conditions: Crerbral Angiography
Being tested: Vascular Interventional Robotic System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vascular Interventional Robotic SystemDevice
The cerebral angiography will be performed by using the vascular interventional robotic system

Study groups in NCT07182188
Study group	Role	What they receive
Traditional Manual Endovascular Angiography	No intervention	Not described
Vascular Interventional Robotic System Assisted Angiography	Experimental	Not described Receives: Device: Vascular Interventional Robotic System

What is being measured

The primary outcome is the main question the study is designed to answer.

Angiography (Clinical) Success Rate
Assessment of the success rate of the surgeon in completing cerebral angiography examination through the operation of vascular interventional robotic system or manual way. Success is confirmed by the criteria: clear visualization of all pre-specified target vessels (without significant imaging artifacts).
Measured: At the end of surgery
Complication Rate
Potential complications include: ① Directly related to the interventional procedure: Vascular injury (vessel rupture, perforation, spasm, gas embolism, and thrombosis); ② Neurological complications: New-onset neurological deficits (transient/permanent), new-onset cerebral ischemia, or new-onset intracerebral hemorrhage, confirmed by postoperative imaging; ③ Systemic complications: Cardiac events, gastrointestinal bleeding, renal dysfunction, etc.
Measured: At the day after surgery
New asymptomatic cerebral infarctions
Assessed via the comparison between the baseline and postoperative (performed within 24 hours post-procedure for all participants) brain magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI)
Measured: Within 24 hours post-procedure

Secondary outcomes (10)

Operation Time
Record and compare the duration of each surgical procedure.
Measured: At the end of surgery
Super-selective Success Rate
Assessing the success rate of the surgeon in performing super-selective catheterization of each cerebral vessels through the operation of vascular interventional robotic system or manual way.
Measured: At the end of surgery
Super-selective Catheterization Time for Vessels
Calculate and compare the average time taken for surgeon to perform super-selective catheterization for each target vessel during each surgical procedure.
Measured: At the end of surgery
Digital Subtraction Angiography (DSA) Fluoroscopy Time
Calculate and compare the average time of fluoroscopy during cerebral angiography for each surgical procedure.
Measured: At the end of surgery
Primary Operator Radiation Absorbed Dose
Record and compare the absorbed dose of radiation received by the primary operator during each surgical procedure.
Measured: At the end of surgery
Participant Radiation Absorbed Dose
Record and compare the absorbed dose of radiation received by the participant during each surgical procedure.
Measured: At the end of surgery
Vascular Interventional Robotic System Performance Evaluation
The surgical physician rate a score (0-10) after the surgery to subjectively evaluate the performance of the vascular interventional robotic system during the angiographic examination procedure.
Measured: At the end of surgery
Frequence of robotic operations transition to manual operations
Document the frequence where robotic operations transition to manual operations due to certain force majeure events.
Measured: At the end of surgery
Operation Preparation Time
Calculate and compare the time from when participants enter the operating room until the primary operator formal start the surgery.
Measured: At the end of Surgery
Technical Failure Rate
any conversion from robotic-assisted to manual operation, or inability to complete the procedure due to robotic system malfunctions (e.g., navigation errors, mechanical arm failure). All technical failure cases are classified as clinical failures in the ITT set and excluded from the PP set.
Measured: At the end of Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202430 Apr 2027

First posted19 Sep 2025
Study start1 Sep 2024
Primary completion30 Apr 2027 (estimated)
Study completion30 Apr 2027 (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 Crerbral AngiographyStudies of the same condition, open and under way.
More trials run by Peking Union Medical College 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
Model description: Per-protocol (PP) set: The PP set includes all randomized participants who: (i) meet all inclusion criteria and none of the exclusion criteria; (ii) receive the allocated procedure modality without major protocol violation; and (iii) complete all primary endpoint assessments without missing data. The PP set is the primary dataset for the non-inferiority test (the non-inferiority margin was -5%) of the primary efficacy endpoint and the key DWI safety endpoint analysis. Intention-to-treat (ITT) set: The ITT set includes all randomized participants, analyzed according to their allocated treatment group regardless of protocol adherence or treatment received. In accordance with the principle, all cases of technical failure in the robotic-assisted group are classified as clinical failures in the ITT analysis. The ITT set is used for sensitivity analysis of the primary endpoint to verify the robustness of non-inferiority conclusions.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 660 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07182188
Sponsor's protocol ID: MR-11-24-024538
Status last verified: Oct 2026
First submitted: 11 Sep 2025
Last updated: 27 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The vascular interventional robotic system includes proprietary technical features that are integral to the IPD. Publicly sharing IPD would inadvertently disclose proprietary information, which could compromise the manufacturer's intellectual property rights and hinder future development of the technology for broader clinical use.

Publications

Liu H, Li C, Ren S, Li T, Zhong H, Jia J, Yang H, Qi Y, Feng J, Li Y, Wang Y. Efficacy and safety of a neurointerventional operation robotic assistance system in cerebral angiography. Stroke Vasc Neurol. 2024 Jun 21;9(3):243-251. doi: 10.1136/svn-2022-002260.
PubMed 37612055
Zhang Y, Xu H, Sun J, Chen WH, Zhang Y, Chen M, Yi T, Wu YM, Cheng G, Guo J, Yang P, Guo S, Liu J. Safety and efficacy of cerebral robot assisted angiography: randomized comparison of robotic versus manual procedures. J Neurointerv Surg. 2026 Apr 16;18(5):1330-1336. doi: 10.1136/jnis-2025-023412.
PubMed 40633938
Beaman C, Gautam A, Peterson C, Kaneko N, Ponce L, Saber H, Khatibi K, Morales J, Kimball D, Lipovac JR, Narsinh KH, Baker A, Caton MT, Smith ER, Nour M, Szeder V, Jahan R, Colby GP, Cord BJ, Cooke DL, Tateshima S, Duckwiler G, Waldau B; Robotics Working Group; Robotic Working Group. Robotic Diagnostic Cerebral Angiography: A Multicenter Experience of 113 Patients. J Neurointerv Surg. 2024 Jun 17;16(7):726-730. doi: 10.1136/jnis-2023-020448.
PubMed 37468266

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Market Application Study and Efficacy/Safety Evaluation of a Vascular Interventional Robotic System for Cerebral Angiography: A Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07182188
Acronym / sponsor ID: MR-11-24-024538
Conditions: Crerbral Angiography
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 660 participants (estimated)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Collaborators: Beijing Tiantan Hospital, The First Hospital of Hebei Medical University, The First Affiliated Hospital of Zhengzhou University, Tangshan Worker's Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Lianyungang
Study start: 1 Sep 2024 (actual)
Primary completion: 30 Apr 2027 (estimated)
Study completion: 30 Apr 2027 (estimated)
First posted: 19 Sep 2025 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Per-protocol (PP) set: The PP set includes all randomized participants who: (i) meet all inclusion criteria and none of the exclusion criteria; (ii) receive the allocated procedure modality without major protocol violation; and (iii) complete all primary endpoint assessments without missing data. The PP set is the primary dataset for the non-inferiority test (the non-inferiority margin was -5%) of the primary efficacy endpoint and the key DWI safety endpoint analysis. Intention-to-treat (ITT) set: The ITT set includes all randomized participants, analyzed according to their allocated treatment group regardless of protocol adherence or treatment received. In accordance with the principle, all cases of technical failure in the robotic-assisted group are classified as clinical failures in the ITT analysis. The ITT set is used for sensitivity analysis of the primary endpoint to verify the robustness of non-inferiority conclusions.

Arm	Type	Receives
Traditional Manual Endovascular Angiography	No intervention	–
Vascular Interventional Robotic System Assisted Angiography	Experimental	Device: Vascular Interventional Robotic System

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age between 18 and 75 years;
Suspected vascular lesions in the head and neck, or other conditions involving head and neck vessels requiring whole-brain angiography for definitive diagnosis or to aid treatment decisions. Including but not limited to: intracranial aneurysms, arteriovenous malformations, cavernous malformations, arteriovenous fistulas, Moyamoya disease, Moyamoya syndrome, subarachnoid hemorrhage, symptomatic intracranial artery stenosis/occlusion, stenosis/occlusion of the carotid/subclavian/vertebral arteries, acute/ chronic subdural hematoma, etc;
American Society of Anesthesiologists (ASA) physical status classification I-III (no severe cardiopulmonary dysfunction);
Patients who voluntarily participate in this study and sign an informed consent form.

Key exclusion criteria (11 listed)

Patients who are to undergo surgery at the same time as cerebral angiography;
Renal dysfunction (serum creatinine > 133 μmol/L or estimated glomerular filtration rate < 60 mL/min/1.73 m²);
Patients with known allergy to iodinated contrast media;
Coagulation disorders (prothrombin time >16s, activated partial thromboplastin time >45s, or platelet count <100×10⁹/L);
Severe infection, skin ulceration, or vascular anatomical abnormalities at the puncture site (e.g., bilateral femoral artery occlusion);

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
Vascular Interventional Robotic SystemThe cerebral angiography will be performed by using the vascular interventional robotic system	Device	Vascular Interventional Robotic System Assisted Angiography

Primary outcome

Angiography (Clinical) Success Rate
Time frame: At the end of surgery
Assessment of the success rate of the surgeon in completing cerebral angiography examination through the operation of vascular interventional robotic system or manual way. Success is confirmed by the criteria: clear visualization of all pre-specified target vessels (without significant imaging artifacts).
Complication Rate
Time frame: At the day after surgery
Potential complications include: ① Directly related to the interventional procedure: Vascular injury (vessel rupture, perforation, spasm, gas embolism, and thrombosis); ② Neurological complications: New-onset neurological deficits (transient/permanent), new-onset cerebral ischemia, or new-onset intracerebral hemorrhage, confirmed by postoperative imaging; ③ Systemic complications: Cardiac events, gastrointestinal bleeding, renal dysfunction, etc.
New asymptomatic cerebral infarctions
Time frame: Within 24 hours post-procedure
Assessed via the comparison between the baseline and postoperative (performed within 24 hours post-procedure for all participants) brain magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI)

10 secondary outcomes

Operation Time
Time frame: At the end of surgery
Super-selective Success Rate
Time frame: At the end of surgery
Super-selective Catheterization Time for Vessels
Time frame: At the end of surgery
Digital Subtraction Angiography (DSA) Fluoroscopy Time
Time frame: At the end of surgery
Primary Operator Radiation Absorbed Dose
Time frame: At the end of surgery
Participant Radiation Absorbed Dose
Time frame: At the end of surgery
Vascular Interventional Robotic System Performance Evaluation
Time frame: At the end of surgery
Frequence of robotic operations transition to manual operations
Time frame: At the end of surgery
Operation Preparation Time
Time frame: At the end of Surgery
Technical Failure Rate
Time frame: At the end of Surgery

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 27 Oct 2026.
Results publication: PubMed 37612055Liu H, Li C, Ren S, Li T, Zhong H, Jia J, Yang H, Qi Y, Feng J, Li Y, Wang Y. Efficacy and safety of a neurointerventional operation robotic assistance system in cerebral angiography. Stroke Vasc Neurol. 2024 Jun 21;9(3):243-251. doi: 10.1136/svn-2022-002260.
Results publication: PubMed 40633938Zhang Y, Xu H, Sun J, Chen WH, Zhang Y, Chen M, Yi T, Wu YM, Cheng G, Guo J, Yang P, Guo S, Liu J. Safety and efficacy of cerebral robot assisted angiography: randomized comparison of robotic versus manual procedures. J Neurointerv Surg. 2026 Apr 16;18(5):1330-1336. doi: 10.1136/jnis-2025-023412.
Results publication: PubMed 37468266Beaman C, Gautam A, Peterson C, Kaneko N, Ponce L, Saber H, Khatibi K, Morales J, Kimball D, Lipovac JR, Narsinh KH, Baker A, Caton MT, Smith ER, Nour M, Szeder V, Jahan R, Colby GP, Cord BJ, Cooke DL, Tateshima S, Duckwiler G, Waldau B; Robotics Working Group; Robotic Working Group. Robotic Diagnostic Cerebral Angiography: A Multicenter Experience of 113 Patients. J Neurointerv Surg. 2024 Jun 17;16(7):726-730. doi: 10.1136/jnis-2023-020448.
Individual participant dataSharing planned: No. The vascular interventional robotic system includes proprietary technical features that are integral to the IPD. Publicly sharing IPD would inadvertently disclose proprietary information, which could compromise the manufacturer's intellectual property rights and hinder future development of the technology for broader clinical use.

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vascular Interventional Robotic System in people with Crerbral Angiography, run by Peking Union Medical College Hospital at 2 sites 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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angiography (Clinical) Success Rate (time frame: At the end of surgery). The study lists 3 primary outcomes in all. 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 NCT07182188, 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 27 Oct 2026.