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

Launched by YAN'AN AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new robotic system called the 5G-Robotic VRS100, which is designed to assist doctors during a procedure known as Percutaneous Coronary Intervention (PCI). PCI is often used to treat patients with coronary artery disease, a condition where the arteries that supply blood to the heart become narrowed or blocked. The main goal of the trial is to assess how safe and effective this robotic system is for patients undergoing this treatment.

To participate in the trial, individuals must be at least 18 years old and have coronary artery disease that requires PCI. Some important eligibility criteria include having a specific type of blockage that can be treated with a single stent and that the blockage is significant enough to require intervention. However, there are several conditions that could exclude someone from participating, such as recent heart attacks, severe heart failure, or certain kidney issues. If eligible, participants will be informed about the study and will need to provide consent before taking part. This trial is not yet recruiting participants, but it aims to pave the way for advanced, robotic-assisted heart procedures in the future.

Gender

ALL

Eligibility criteria

• 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 informed consent.
• * 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:
• * 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 (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.
• * 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.