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Not yet recruitingNCT06213714Updated Jan 19, 2024

The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial

An interventional study of 5G Tele-Robotic-Assisted PCI in Coronary Artery Disease, Myocardial Ischemia and Cardiovascular Diseases, sponsored by Yan'an Affiliated Hospital of Kunming Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Yan'an Affiliated Hospital of Kunming Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to examine the safety and effectiveness, from both clinical and technical perspectives, of utilizing the 5G-Robotic VRS100 system in percutaneous coronary intervention (PCI).

02

Conditions studied

  • Coronary Artery Disease
  • Myocardial Ischemia
  • Cardiovascular Diseases
  • Coronary Disease
  • Arteriosclerosis
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 12 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Yan'an Affiliated Hospital of Kunming Medical University is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • General Inclusion Criteria:

    1. Age ≥18 years.
    2. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI).
    3. The subject has been informed of the nature of the study, agrees to its provisions and has provided written .

  • Angiographic Inclusion Criteria:

    1. De-novo coronary artery disease.
    2. Reference vessel diameter is 2.5-4.0mm by visual estimate.
    3. Target lesion length is ≤30.0mm.
    4. Target lesion is a single de-novo native coronary artery lesion. This lesion may consist of multiple lesions (with ≤10mm between diseased segments) and must be completely covered by a single stent with ≥5.0mm of normal segments on proximal and distal edges of the lesion.
    5. Target lesion diameter showing stenosis ≥70% by visual estimate, or ≥50% with myocardial ischemia.
    6. Target lesion angiography meets the calculation criteria of Rui-Xin AngioQFA, and AngioQFA is ≤0.8.

Exclusion criteria

Exclusion Criteria:

  • Patients meeting any of the following criteria will be excluded:

  • General Exclusion Criteria:

    1. Subjects with indications for urgent PCI surgery.
    2. Evidence of an acute myocardial infarction within one week prior to the intended VRS100 procedure.
    3. Subject has undergone PCI within 72 hours prior to the VRS100 procedure.
    4. Subject has undergone PCI within 30 days prior to the VRS100 procedure and experienced a MACE or a serious adverse event (SAE).
    5. Severe heart failure ( IV \& ≤35%).
    6. Subject has suffered a stroke, or has an active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to planned VRS100 procedure.
    7. Subject has known or to aspirin, heparin, ticagrelor, clopidogrel, bivalirudin, PTX(paclitaxel), stainless steel, etc.
    8. Subject has acute or chronic kidney disease (serum creatinine level of >2.5 mg/dL or >221 umol/L) or need dialysis.
    9. Pregnant or breastfeeding, or planning to be pregnant.
    10. Repeated enrollment.
    11. Any other factors that the researchers consider not suitable for inclusion or completion of this study.

  • Angiographic Exclusion Criteria:

    1. Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.
    2. Target lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement.
    3. Cardiac allograft vasculopathy (CAV).
    4. Target lesion/vessel has evidence of intraluminal thrombus.
    5. Chronic total occlusion (CTO).
    6. Target lesion located in a native vessel distal to an ostial, bifurcation or anastomosis.
    7. Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.
    8. Target lesion or vessel proximal to the target lesion has severe tortuosity or calcification.
    9. Target lesion that cannot be fully covered by a single stent.
    10. More than 2 lesions requires treatment in one vessel.
    11. Subject requires treatment of more than one vessel.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    5G Tele-Robotic-Assisted PCI

    VRS100 Robotic Console System, was developed by Shenzhen Raysight Intelligent Medical Technology Co., Ltd., will be used for 5G Tele-Robotic-Assisted Percutaneous Coronary Intervention in this study.

    Device: 5G Tele-Robotic-Assisted PCI

Interventions

  • Device5G Tele-Robotic-Assisted PCI

    The 5G Tele-Robotic-Assisted VRS100 system is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

    Also known as: VRS100 Robotic Console System

06

What researchers measure

Primary outcomes

  1. Clinical Success

    Defined as angiographic success (residual stenosis after stenting of \<30% with final TIMI \[Thrombolysis In Myocardial Infarction\] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (cardiovascular death, MI, clinically driven target vessel revascularization).

    Time frame: 48 hours or hospital discharge, whichever occurs first

  2. Technical Success

    Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.

    Time frame: 1 day

Secondary outcomes

  1. PCI Procedure Time

    Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

    Time frame: During procedure

  2. Overall Procedure Time

    Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

    Time frame: During procedure

  3. Fluoroscopy and/or X-Ray Time

    As recorded by an X-Ray System utilized during the procedure.

    Time frame: During procedure

  4. Patient Radiation Exposure - Cumulative Dose

    Cumulative dose (mGy) as recored during the procedure.

    Time frame: During procedure

  5. Contrast Fluid Volume

    The amount of contrast fluid used (mL) during the procedure.

    Time frame: During procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2024; primary completion for Jun 2024, 4 months later.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 4 months is below that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2024
First posted
Jan 19, 2024
StartEst.
Feb 2024
Primary completionEst.
Jun 2024
CompletionEst.
Sep 2024
Last update
Jan 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06213714
Lead sponsor
Yan'an Affiliated Hospital of Kunming Medical University
Collaborators
Shanghai Zhongshan Hospital, Kunming Chenggong District People's Hospital
Responsible party
Sponsor
First posted
Jan 19, 2024
Start date
Feb 2024 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jan 19, 2024

Study contacts

Qiang Xue
Contact
Xueqiang3513@126.com
13987199913
Lihui Li
Contact
lihui.li@raysightmed.com
13636480344
Junbo Ge
study chair · Shanghai Zhongshan Hospital
Chenguang Li
principal investigator · Shanghai Zhongshan Hospital
Qiang Xue
principal investigator · Yan'an Affiliated Hospital of Kunming Medical University
Wangxiong Li
principal investigator · Kunming Chenggong District People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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