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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Vascular Disease Occlusive
• Intervention / Treatment: Procedure: VRS100 robotic-assisted PCI; Procedure: Manual PCI

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lihui Li; Phone Number: 13636480344; Email: lihui.li@raysightmed.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • Shenzhen People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital
  • Sichuang
    • Chengdu, Sichuang, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. In situ primary coronary vascular 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.

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).
  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. 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.
  3. Cardiac allograft vasculopathy (CAV).
  4. The study vessel has evidence of intraluminal thrombus.
  5. Chronic total occlusion (CTO).
  6. The study 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. The study 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Overall Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	During procedure
PCI Procedure Time	Defined as the time measured from the insertion of the guide catheter 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
Contrast Fluid Volume	The amount of contrast fluid used (mL) during the procedure.	During procedure
Patient Radiation Exposure - Cumulative Dose	Cumulative dose (mGy) as recored during the procedure.	During procedure
Performance of the Experimental Device	The frequency of failures and performance evaluation	During procedure

Collaborators and Investigators

• Sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
• Collaborators: Shanghai Zhongshan Hospital; West China Hospital; Shenzhen People's Hospital
• Investigators: Study Director: Junbo Ge, Shanghai Zhongshan Hospital; Principal Investigator: Yong He, West China Hospital; Principal Investigator: Da Yin, Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 8, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Vascular Diseases; Ischemia; Arteriosclerosis
• Other Study ID Numbers: VRS100 System

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No