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

NCT06032572 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2023-09-13

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Manual PCI

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

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • Shenzhen Raysight Intelligent Medical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junbo Ge · Shanghai Zhongshan Hospital

  • Yong He · West China Hospital

  • Da Yin · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032572 on ClinicalTrials.gov