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Robot takes the wheel in heart surgery trial

NCT ID NCT07233317

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.