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

Shenzhen Raysight Intelligent Medical Technology Co., Ltd.3 sites in 1 country204 target enrollmentSeptember 8, 2023

ConditionsCoronary Artery Disease Cardiovascular Diseases Coronary Disease Myocardial Ischemia Arteriosclerosis Vascular Disease Occlusive

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Enrollment: 204
Locations: 3
Primary Endpoint: Technical Success
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

September 8, 2023

End Date

August 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shenzhen Raysight Intelligent Medical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Clinical Success

Time Frame: 48-hrs 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).