Robot takes the wheel in heart surgery trial
NCT ID NCT07233317
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a robotic system can safely assist doctors in opening blocked heart arteries. About 170 adults with coronary artery disease will be randomly assigned to receive the standard procedure or one assisted by the robot. The goal is to see if the robot can reduce procedure time and radiation exposure while maintaining success rates.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 1. Underwent other PCI within 72 hours before the PCI procedure. 2. Underwent PCI within 30 days before the PCI procedure and experienced a Major Adverse Cardiovascular Event (MACE). 3. Experienced acute Myocardial Infarction (MI) within one week before the PCI procedure. 4. Experienced cardiogenic shock within 48 hours before the PCI procedure. 5. Had a stroke within 30 days before the PCI procedure. 6. Subjects with active peptic ulcer or upper gastrointestinal bleeding within 6 months before the PCI procedure. 7. Severe heart failure (NYHA Class IV). 8. Pregnant and lactating women, or women planning to become pregnant during the clinical trial period. 9. Known allergy to aspirin, heparin, clopidogrel, contrast agents, metal materials, etc. 10. Patients with acute or chronic kidney disease (e.g., serum creatinine \>2.5 mg/dL or \>221 µmol/L) or on dialysis. 11. Subjects with a history of major bleeding or coagulation disorders within the past 6 months. 12. Subjects currently participating in another clinical study that has not completed the entire follow-up period. 13. The investigator determines that the patient has other conditions unsuitable for PCI assisted by the vascular interventional robotic system. 14. Requiring other treatment modalities (such as rotational atherectomy or laser therapy) in addition to balloon angioplasty and stent angioplasty. 15. Presence of more than two lesions in a single vessel requiring simultaneous treatment. 16. Presence of visible thrombus. 17. The target lesion is located in the left main coronary artery. 18. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Xicheng District, 100037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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