Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the VRS100 system with disposable surgical kit in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).

Official Title
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Evaluation of the Safety and Effectiveness of the VRS100 Robotic Console System in Percutaneous Coronary Interventions: A Multicenter, Randomised, Non-inferiority Trial (ESSENCE)

Conditions
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Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease, Myocardial Ischemia, Arteriosclerosis, Vascular Disease Occlusive

Intervention / Treatment
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* Procedure: VRS100 robotic-assisted PCI
* Procedure: Manual PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: In situ primary coronary vascular disease. 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. Exclusion Criteria: 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). Severe heart failure (NYHA IV). 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. The study 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). The study vessel has evidence of intraluminal thrombus. Chronic total occlusion (CTO). The study 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. The study 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRS100 robotic-assisted PCI<br>VRS100 robotic-assisted PCI | Procedure: VRS100 robotic-assisted PCI<br>* The VRS100 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.<br>|
| Active Comparator: Manual PCI<br>Manual PCI | Procedure: Manual PCI<br>* Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 48-hrs 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCI Procedure Time | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. | During procedure | 
| Overall Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. | During procedure | 
| Fluoroscopy and/or X-Ray Time | As recorded by an X-Ray System utilized during the procedure. | During procedure | 
| Patient Radiation Exposure - Cumulative Dose | Cumulative dose (mGy) as recored during the procedure. | During procedure | 
| Contrast Fluid Volume | The amount of contrast fluid used (mL) during the procedure. | During procedure | 
| Performance of the Experimental Device | The frequency of failures and performance evaluation | During procedure |