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Multicenter Registry on Robotically Assisted PCI - TESLA

NCT05841745 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2024-07-11

No results posted yet for this study

Summary

MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Corindus Vascular, Siemens Healthineers, Germany) in real-world interventional cardiology practice.

Conditions

Interventions

DEVICE

Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. The CorPath GRX System is composed of two units; the first is a bedside unit which consists of the extended robotic arm, robotic drive, and single-use loading cassette, and the second is the remote workstation, which consists of the interventional cockpit and the control console. A key innovation of the CorPath GRX System is the software-based automation of common maneuvers, called technIQ automated movements with the potential to increase procedural success, reduce procedure time, and generally increase user comfort with robotic assistance during PCI.

Sponsors & Collaborators

  • Corindus, Inc. dba Siemens Healthineers Endovascular Robotics

    collaborator UNKNOWN

  • KCRI Sp. z o.o.

    collaborator UNKNOWN

  • Clinical Research Center, Intercard Sp. z o.o.

    lead INDUSTRY

Principal Investigators

  • Dariusz Dudek, MD, PhD · Clinical Research Center Intercard

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-12-31
Completion
2024-07-31
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • Japan
  • Poland
  • Spain

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 NCT05841745 on ClinicalTrials.gov