The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial
NCT ID: NCT06213714
Last Updated: 2024-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
12 participants
INTERVENTIONAL
2024-02-29
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
5G 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.
Interventions
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5G 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 informed consent.
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
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 (NYHA IV \& LVEF≤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 hypersensitivity or contraindication 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.
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.
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Kunming Chenggong District People's Hospital
UNKNOWN
Yan'an Affiliated Hospital of Kunming Medical University
OTHER
Responsible Party
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Principal Investigators
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Junbo Ge
Role: STUDY_CHAIR
Shanghai Zhongshan Hospital
Chenguang Li
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Qiang Xue
Role: PRINCIPAL_INVESTIGATOR
Yan'an Affiliated Hospital of Kunming Medical University
Wangxiong Li
Role: PRINCIPAL_INVESTIGATOR
Kunming Chenggong District People's Hospital
Central Contacts
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Other Identifiers
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5G Tele-Robotic-Assisted PCI
Identifier Type: -
Identifier Source: org_study_id
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