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

NCT06032572 | Unknown

• 1 other identifier: VRS100 System
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• PCI Procedure Time

  During procedure

• Overall Procedure Time

  During procedure

• Fluoroscopy and/or X-Ray Time

  During procedure

• Patient Radiation Exposure - Cumulative Dose

  During procedure

• Contrast Fluid Volume

  During procedure

Study Arms (2)

VRS100 robotic-assisted PCI

EXPERIMENTAL

VRS100 robotic-assisted PCI

Procedure: VRS100 robotic-assisted PCI

Manual PCI

ACTIVE COMPARATOR

Manual PCI

Procedure: Manual PCI

Interventions

VRS100 robotic-assisted PCI PROCEDURE

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.

VRS100 robotic-assisted PCI

Manual PCI PROCEDURE

Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.

Manual PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients meeting any of the following criteria will be excluded:
• 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 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.

Sponsors & Collaborators

• Shenzhen Raysight Intelligent Medical Technology Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator
• West China Hospital: collaborator
• Shenzhen People's Hospital: collaborator

Study Sites (3)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuang, 610041, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis

Condition Hierarchy (Ancestors)

Heart Diseases; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

• Yong He

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Da Yin

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihui Li

CONTACT

13636480344; lihui.li@raysightmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: September 8, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)