Coronary Artery DiseaseNCT07233317
Evaluating the Safety and Effectiveness of a Vascular Interventional Robotic System in Assisting With Percutaneous Coronary Intervention Procedures: A Prospective, Multicenter, Randomized Controlled Clinical Trial
A study testing vascular interventional robotic system and human operator in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this clinical trial is to verify the safety and effectiveness of the vascular interventional robotic system developed and manufactured by Beijing Zhongke Hongtai Medical Technology Co., Ltd. in assisting percutaneous coronary intervention procedures in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- vascular interventional robotic system and human operator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Jun 2026
- 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
- 1.18 years ≤ Age ≤ 80 years; 2.Presence of clinical indications for PCI and requiring PCI treatment; 3.The subject or their legal guardian is able to understand the trial objectives, voluntarily signs the informed consent form, and is willing to comply with follow-up procedures.
- 4.Visual estimation of target lesion diameter stenosis ≥70% (or ≥50% with clinical evidence of myocardial ischemia); 5.2.25 mm ≤ Visual reference vessel diameter ≤ 4.0 mm; 6.The target lesion can be fully covered by a single stent, with at least 2.0 mm of normal vessel segment at the proximal and distal edges of the lesion; 7.Number of target vessels requiring treatment ≤ 2; one target lesion treated with one stent; staged treatment of the target lesion is not allowed.
Who cannot join
- Underwent other PCI within 72 hours before the PCI procedure.
- Underwent PCI within 30 days before the PCI procedure and experienced a Major Adverse Cardiovascular Event (MACE).
- Experienced acute Myocardial Infarction (MI) within one week before the PCI procedure.
- Experienced cardiogenic shock within 48 hours before the PCI procedure.
- Had a stroke within 30 days before the PCI procedure.
- Subjects with active peptic ulcer or upper gastrointestinal bleeding within 6 months before the PCI procedure.
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- Severe heart failure (NYHA Class IV).
- Pregnant and lactating women, or women planning to become pregnant during the clinical trial period.
- Known allergy to aspirin, heparin, clopidogrel, contrast agents, metal materials, etc.
- Patients with acute or chronic kidney disease (e.g., serum creatinine >2.5 mg/dL or >221 µmol/L) or on dialysis.
- Subjects with a history of major bleeding or coagulation disorders within the past 6 months.
- Subjects currently participating in another clinical study that has not completed the entire follow-up period.
- The investigator determines that the patient has other conditions unsuitable for PCI assisted by the vascular interventional robotic system.
- Requiring other treatment modalities (such as rotational atherectomy or laser therapy) in addition to balloon angioplasty and stent angioplasty.
- Presence of more than two lesions in a single vessel requiring simultaneous treatment.
- Presence of visible thrombus.
- The target lesion is located in the left main coronary artery.
- Severely tortuous lesions, severely calcified lesions, or other complex vascular conditions deemed by the investigator as unsuitable for PCI assisted by the vascular interventional robotic system.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Xicheng District, 100037
Bowen Li, 01088396584, libowen@fuwai.com
About this study
The goal of this clinical trial is to verify the safety and effectiveness of the vascular interventional robotic system developed and manufactured by Beijing Zhongke Hongtai Medical Technology Co., Ltd. in assisting percutaneous coronary intervention procedures in patients with coronary artery disease. The main question it aims to answer is:
- Whether the PCI-assisted procedure was clinically successful and technically successful?
- Will the PCI-assisted procedure can reduce procedure time, PCI time, and radiation exposure for both operators and patients?? Researchers will compare the vascular interventional robotic system with human operators to see if using the vascular interventional robotic system in PCI procedure is effective and safe.
Participants will undergo percutaneous coronary interventions with the vascular interventional robotic system or human operator based on the randomization results. Then all participants will receive a 1-month follow up to evaluate the primary and secondary endpoints.
- Conditions
- Coronary Artery Disease
- Being tested
- vascular interventional robotic system, human operator
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular interventional robotic systemDevice
Patients all undergoing PCI with vascular interventional robotic system
human operatorDevice
Patients undergoing PCI by human operators
| Study group | Role | What they receive |
|---|---|---|
| vascular interventional robotic system group | Experimental | Undergoing PCI using the vascular interventional robotic group Receives: Device: vascular interventional robotic system |
| human operator group | Other | Undergoing PCI with human operators Receives: Device: human operator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate
Measured: Immediately after PCI
Technical Success Rate
Measured: Immediately after PCI
Secondary outcomes (10)
Total procedure time
Measured: Immediately after PCI
PCI time
Measured: Immediately after PCI
Rate of Successful Guiding Catheter Manipulation
Measured: Immediately after PCI
Patient Radiation Exposure
Measured: Immediately after PCI
Radiation Exposure to Operators and Assistant Physicians
Measured: Immediately after PCI
Contrast Agent Volume
Measured: Immediately after PCI
Product Performance Evaluation
Measured: Immediately after PCI
Incidence of Major Adverse Cardiovascular Events (MACE)
Measured: Immediately after PCI and 1 month after PCI
Incidence of Adverse Events and Serious Adverse Events
Measured: Immediately after PCI and 1 month after PCI
Incidence of Device Deficiencies
Measured: Immediately after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233317
- Sponsor's protocol ID
- 2025-2800
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD will not be shared for consideration of personal privacy
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Effectiveness of a Vascular Interventional Robotic System in Assisting With Percutaneous Coronary Intervention Procedures: A Prospective, Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07233317
- Acronym / sponsor ID
- 2025-2800
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Nov 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.
The goal of this clinical trial is to verify the safety and effectiveness of the vascular interventional robotic system developed and manufactured by Beijing Zhongke Hongtai Medical Technology Co., Ltd. in assisting percutaneous coronary intervention procedures in patients with coronary artery disease. The main question it aims to answer is:
- Whether the PCI-assisted procedure was clinically successful and technically successful?
- Will the PCI-assisted procedure can reduce procedure time, PCI time, and radiation exposure for both operators and patients?? Researchers will compare the vascular interventional robotic system with human operators to see if using the vascular interventional robotic system in PCI procedure is effective and safe.
Participants will undergo percutaneous coronary interventions with the vascular interventional robotic system or human operator based on the randomization results. Then all participants will receive a 1-month follow up to evaluate the primary and secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vascular interventional robotic system group | Experimental | Device: vascular interventional robotic systemUndergoing PCI using the vascular interventional robotic group |
| human operator group | Other | Device: human operatorUndergoing PCI with human operators |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.18 years ≤ Age ≤ 80 years; 2.Presence of clinical indications for PCI and requiring PCI treatment; 3.The subject or their legal guardian is able to understand the trial objectives, voluntarily signs the informed consent form, and is willing to comply with follow-up procedures.
- 4.Visual estimation of target lesion diameter stenosis ≥70% (or ≥50% with clinical evidence of myocardial ischemia); 5.2.25 mm ≤ Visual reference vessel diameter ≤ 4.0 mm; 6.The target lesion can be fully covered by a single stent, with at least 2.0 mm of normal vessel segment at the proximal and distal edges of the lesion; 7.Number of target vessels requiring treatment ≤ 2; one target lesion treated with one stent; staged treatment of the target lesion is not allowed.
Key exclusion criteria (18 listed)
- Underwent other PCI within 72 hours before the PCI procedure.
- Underwent PCI within 30 days before the PCI procedure and experienced a Major Adverse Cardiovascular Event (MACE).
- Experienced acute Myocardial Infarction (MI) within one week before the PCI procedure.
- Experienced cardiogenic shock within 48 hours before the PCI procedure.
- Had a stroke within 30 days before the PCI procedure.
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 systemPatients all undergoing PCI with vascular interventional robotic system | Device | vascular interventional robotic system group |
| human operatorPatients undergoing PCI by human operators | Device | human operator group |
Primary outcome
Clinical Success Rate
Time frame: Immediately after PCI
Technical Success Rate
Time frame: Immediately after PCI
10 secondary outcomes
Total procedure time
Time frame: Immediately after PCI
PCI time
Time frame: Immediately after PCI
Rate of Successful Guiding Catheter Manipulation
Time frame: Immediately after PCI
Patient Radiation Exposure
Time frame: Immediately after PCI
Radiation Exposure to Operators and Assistant Physicians
Time frame: Immediately after PCI
Contrast Agent Volume
Time frame: Immediately after PCI
Product Performance Evaluation
Time frame: Immediately after PCI
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Immediately after PCI and 1 month after PCI
Incidence of Adverse Events and Serious Adverse Events
Time frame: Immediately after PCI and 1 month after PCI
Incidence of Device Deficiencies
Time frame: Immediately after PCI
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 18 Nov 2025.
- Individual participant dataSharing planned: No. All IPD will not be shared for consideration of personal privacy
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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.
1 site 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 and human operator in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases 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 2 inclusion and 18 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: opening soon, as of the sponsor's last update on 18 Nov 2025. 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 Bowen Li (01088396584, libowen@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate (time frame: Immediately after PCI). 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 18 Nov 2025.