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

NCT06213714 | Unknown

• 1 other identifier: 5G Tele-Robotic-Assisted PCI
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to examine the safety and effectiveness, from both clinical and technical perspectives, of utilizing the 5G-Robotic VRS100 system in percutaneous coronary intervention (PCI).

Conditions

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

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 hours 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 (5)

• 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 (1)

5G Tele-Robotic-Assisted PCI

EXPERIMENTAL

VRS100 Robotic Console System, was developed by Shenzhen Raysight Intelligent Medical Technology Co., Ltd., will be used for 5G Tele-Robotic-Assisted Percutaneous Coronary Intervention in this study.

Device: 5G Tele-Robotic-Assisted PCI

Interventions

5G Tele-Robotic-Assisted PCI DEVICE

The 5G Tele-Robotic-Assisted VRS100 system 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.

Also known as: VRS100 Robotic Console System

5G Tele-Robotic-Assisted 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.
• De-novo coronary artery 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.
• Target lesion angiography meets the calculation criteria of Rui-Xin AngioQFA, and AngioQFA is ≤0.8.

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 \& LVEF≤35%).
• 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.
• Target 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).
• Target lesion/vessel has evidence of intraluminal thrombus.

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead
• Shanghai Zhongshan Hospital: collaborator
• Kunming Chenggong District People's Hospital: collaborator

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge

  Shanghai Zhongshan Hospital

  STUDY CHAIR

• Chenguang Li

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Qiang Xue

  Yan'an Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

• Wangxiong Li

  Kunming Chenggong District People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Xue

CONTACT

13987199913; Xueqiang3513@126.com

Lihui Li

CONTACT

13636480344; lihui.li@raysightmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share