Cerebral AngiographyNCT05778214
A Clinical Trial for the Interventional Robotic System
A study testing Interventional Robotic System in people with Cerebral Angiography, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebral Angiography
- What is being tested?
- Interventional Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 85 years;
- Plan to undergo cerebral angiography;
- Voluntarily participated in this trial and signed the informed consent form.
Who cannot join
- Preoperative mRS score >2;
- Allergy or intolerance to iodine contrast media;
- Allergy to interventional devices;
- Severe cardiac, hepatic and renal insufficiency;
- Active systemic infection;
- Severe stenosis, occlusion or skin infection at the puncture site;
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- Subjects who are to undergo surgery at the same time as cerebral angiography;
- Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin);
- Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening;
- Female subjects of childbearing age who are pregnant or breastfeeding;
- Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai City
Jianming liu, 008613901780638, chzhanghj@smmu.edu.cn
About this study
Official title: A Multi-Center, Randomized, Non-Inferiority, Prospective and Parallel-Group Trial to Evaluate the Safety and Efficacy of the Interventional Robotic System for Cerebral Angiography
The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.
- Conditions
- Cerebral Angiography
- Being tested
- Interventional Robotic System
- Keywords
- Cerebral Angiography, Interventional Surgical Robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional Robotic SystemDevice
Cerebral angiography was performed by using the interventional robotic system
| Study group | Role | What they receive |
|---|---|---|
| Interventional Robotic System Assisted Surgery | Experimental | Experimental group underwent cerebral angiography using the vascular interventional surgical control system Receives: Device: Interventional Robotic System |
| Traditional Manual Surgery | No intervention | The control group process the traditional manual operation for cerebral angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate
Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means.
Measured: at the end of surgery
Secondary outcomes (6)
Super-selective Technique Success Rate
Assessing the technical success rate of the surgical physician in performing super-selective catheterization of cerebral vessels through the operation of experimental instruments or artificial means.
Measured: at the end of surgery
Super-selective Catheterization Time for Target Vessels
Calculate and compare the average time taken to perform super-selective catheterization for each target vessel during each surgical procedure.
Measured: at the end of surgery
DSA Fluoroscopy Time
Record and compare the duration of fluoroscopy during DSA for each surgical procedure.
Measured: at the end of surgery
Surgical Time
Record and compare the duration of each surgical procedure.
Measured: at the end of surgery
Primary Operator Radiation Absorbed Dose
Record and compare the absorbed dose of ionizing radiation received by the primary operator during each surgical procedure.
Measured: at the end of surgery
Instrument Performance Evaluation
The surgical physician fills out a form after the surgery to subjectively evaluate the performance of the experimental instruments during the angiographic examination procedure.
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.
- First posted21 Mar 2023
- Study start28 Feb 2023
- Primary completion31 Jan 2024 (estimated)
- Study completionDec 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 Changhai 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-min Liu, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778214
- Sponsor's protocol ID
- P01-QR-003
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Non-Inferiority, Prospective and Parallel-Group Trial to Evaluate the Safety and Efficacy of the Interventional Robotic System for Cerebral Angiography
- ClinicalTrials.gov ID
- NCT05778214
- Acronym / sponsor ID
- P01-QR-003
- Conditions
- Cerebral Angiography
- Keywords
- Cerebral Angiography, Interventional Surgical Robot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Mar 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 multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Robotic System Assisted Surgery | Experimental | Device: Interventional Robotic SystemExperimental group underwent cerebral angiography using the vascular interventional surgical control system |
| Traditional Manual Surgery | No intervention | –The control group process the traditional manual operation for cerebral angiography |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 and ≤ 85 years;
- Plan to undergo cerebral angiography;
- Voluntarily participated in this trial and signed the informed consent form.
Key exclusion criteria (11 listed)
- Preoperative mRS score >2;
- Allergy or intolerance to iodine contrast media;
- Allergy to interventional devices;
- Severe cardiac, hepatic and renal insufficiency;
- Active systemic infection;
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 |
|---|---|---|
| Interventional Robotic SystemCerebral angiography was performed by using the interventional robotic system | Device | Interventional Robotic System Assisted Surgery |
Primary outcome
Clinical Success Rate
Time frame: at the end of surgery
Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means.
6 secondary outcomes
Super-selective Technique Success Rate
Time frame: at the end of surgery
Super-selective Catheterization Time for Target Vessels
Time frame: at the end of surgery
DSA Fluoroscopy Time
Time frame: at the end of surgery
Surgical Time
Time frame: at the end of surgery
Primary Operator Radiation Absorbed Dose
Time frame: at the end of surgery
Instrument Performance Evaluation
Time frame: at the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Robotic System in people with Cerebral Angiography, run by Changhai 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 3 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: status not confirmed, as of the sponsor's last update on 21 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate (time frame: at the end of surgery). 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 NCT05778214, 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 21 Mar 2023.