Coronary Artery DiseaseNCT06213714
The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial
A study testing 5G Tele-Robotic-Assisted PCI in people with Coronary Artery Disease and Myocardial Ischemia, run by Yan'an Affiliated Hospital of Kunming Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases
- What is being tested?
- 5G Tele-Robotic-Assisted PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- Age ≥18 years.
- Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI).
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Angiographic Inclusion Criteria:
- De-novo coronary artery disease.
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- Reference vessel diameter is 2.5-4.0mm by visual estimate.
- Target lesion length is ≤30.0mm.
- 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.
- Target lesion diameter showing stenosis ≥70% by visual estimate, or ≥50% with myocardial ischemia.
- Target lesion angiography meets the calculation criteria of Rui-Xin AngioQFA, and AngioQFA is ≤0.8.
Who cannot join
- Patients meeting any of the following criteria will be excluded:
- General Exclusion Criteria:
- Subjects with indications for urgent PCI surgery.
- Evidence of an acute myocardial infarction within one week prior to the intended VRS100 procedure.
- Subject has undergone PCI within 72 hours prior to the VRS100 procedure.
- Subject has undergone PCI within 30 days prior to the VRS100 procedure and experienced a MACE or a serious adverse event (SAE).
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- Severe heart failure (NYHA IV \& LVEF≤35%).
- Subject has suffered a stroke, or has an active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to planned VRS100 procedure.
- Subject has known hypersensitivity or contraindication to aspirin, heparin, ticagrelor, clopidogrel, bivalirudin, PTX(paclitaxel), stainless steel, etc.
- Subject has acute or chronic kidney disease (serum creatinine level of >2.5 mg/dL or >221 umol/L) or need dialysis.
- Pregnant or breastfeeding, or planning to be pregnant.
- Repeated enrollment.
- Any other factors that the researchers consider not suitable for inclusion or completion of this study.
- Angiographic Exclusion Criteria:
- Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.
- Target lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement.
- Cardiac allograft vasculopathy (CAV).
- Target lesion/vessel has evidence of intraluminal thrombus.
- Chronic total occlusion (CTO).
- Target lesion located in a native vessel distal to an ostial, bifurcation or anastomosis.
- Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.
- Target lesion or vessel proximal to the target lesion has severe tortuosity or calcification.
- Target lesion that cannot be fully covered by a single stent.
- More than 2 lesions requires treatment in one vessel.
- Subject requires treatment of more than one vessel.
Trial locations and contacts
No sites are listed yet.
About this study
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).
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Coronary Disease, Arteriosclerosis
- Being tested
- 5G Tele-Robotic-Assisted PCI
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Coronary Disease, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5G Tele-Robotic-Assisted PCIDevice
Also called VRS100 Robotic Console System
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.
| Study group | Role | What they receive |
|---|---|---|
| 5G Tele-Robotic-Assisted PCI | Experimental | 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. Receives: Device: 5G Tele-Robotic-Assisted PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours or hospital discharge, whichever occurs first
Technical Success
Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.
Measured: 1 day
Secondary outcomes (5)
PCI Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Measured: During procedure
Overall Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Measured: During procedure
Fluoroscopy and/or X-Ray Time
As recorded by an X-Ray System utilized during the procedure.
Measured: During procedure
Patient Radiation Exposure - Cumulative Dose
Cumulative dose (mGy) as recored during the procedure.
Measured: During procedure
Contrast Fluid Volume
The amount of contrast fluid used (mL) during the procedure.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Kunming Chenggong District People's Hospital
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Study chair, Shanghai Zhongshan HospitalChenguang Li, Principal investigator, Shanghai Zhongshan HospitalQiang Xue, Principal investigator, Yan'an Affiliated Hospital of Kunming Medical UniversityWangxiong Li, Principal investigator, Kunming Chenggong District People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213714
- Sponsor's protocol ID
- 5G Tele-Robotic-Assisted PCI
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial
- ClinicalTrials.gov ID
- NCT06213714
- Acronym / sponsor ID
- 5G Tele-Robotic-Assisted PCI
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Coronary Disease, Arteriosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Kunming Chenggong District People's Hospital
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Jan 2024 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5G Tele-Robotic-Assisted PCI | Experimental | Device: 5G Tele-Robotic-Assisted PCIVRS100 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- General Inclusion Criteria:
- Angiographic Inclusion Criteria:
Key exclusion criteria (25 listed)
- Patients meeting any of the following criteria will be excluded:
- General Exclusion Criteria:
- Angiographic Exclusion Criteria:
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 |
|---|---|---|
| 5G Tele-Robotic-Assisted PCIAlso: VRS100 Robotic Console SystemThe 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. | Device | 5G Tele-Robotic-Assisted PCI |
Primary outcome
Clinical Success
Time frame: 48 hours or hospital discharge, whichever occurs first
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).
Technical Success
Time frame: 1 day
Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.
5 secondary outcomes
PCI Procedure Time
Time frame: During procedure
Overall Procedure Time
Time frame: During procedure
Fluoroscopy and/or X-Ray Time
Time frame: During procedure
Patient Radiation Exposure - Cumulative Dose
Time frame: During procedure
Contrast Fluid Volume
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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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.
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
Questions about this trial
What is this clinical trial studying?
A study testing 5G Tele-Robotic-Assisted PCI in people with Coronary Artery Disease and Myocardial Ischemia, run by Yan'an Affiliated Hospital of Kunming Medical University.
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 11 inclusion and 25 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Qiang Xue (13987199913, Xueqiang3513@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 48 hours or hospital discharge, whichever occurs first). 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 19 Jan 2024.