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NCT Number: NCT05841745

Multicenter Registry on Robotically Assisted PCI - TESLA

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hartcentrum OLV Aalst, Aalst, Belgium

Loading trial locations.

About this study

R-PCI represents a novel approach to performing PCI with several studies showing high technical success and low complication rates. The CorPath GRX System is the second generation of the CorPath platform, dedicated to advancing robotic-assisted vascular procedures to mitigate the orthopaedic and radiation-related occupational hazards associated with the practice of interventional cardiology.

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 (Siemens Healthineers, Germany) in real-world interventional cardiology practice in Europe and Asia.

All patients who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System and completed one-year follow-up are eligible for recruitment in this registry, if older than 18 years. This study includes patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI).

The Study Investigators expect to enroll at least 700 patients (up to 1000). International centers that performed R-PCI with the CorPath GRX System will be invited to participate in this multicenter study.

Baseline, procedural, and follow-up data will be collected for all cases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 18 years,
  • Patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI),
  • Coronary artery lesions considered suitable for R-PCI with CorPath GRX System.

Exclusion criteria

  • Unwillingness to provide informed consent (only if applicable).

Treatment and study plan

Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System

Device

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.

Primary outcomes

  1. Number of participants with clinically successful PCI

    Time frame: From time of procedure until date of first event or death from any cause, which came first, assessed up to the time of discharge in the index hospitalization

    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) (death, target vessel MI, or need of repeat target vessel revascularization);

Secondary outcomes

  1. Number of participants with ischemia-driven target lesion revascularization (TLR)

    Time frame: 1 year post-procedure

    Ischemia-driven target lesion revascularization (TLR), at 1 year defined according to the Academic Research Consortium (ARC) criteria;

  2. Number of participants with target lesion failure (TLF)

    Time frame: 1 year post-procedure

    Target lesion failure (TLF) at 1 year, the composite of ARC-defined cardiac death, target vessel MI, or ischemia-driven TLR;

  3. Number of participants with target vessel failure (TVF)

    Time frame: 1 year post-procedure

    Target vessel failure (TVF) at 1 year, the composite of ARC-defined cardiac death, target vessel MI, or ischemia-driven TVR.

  4. Procedure time

    Time frame: During the procedure

    The time recorded from initial guidewire insertion into the robotic drive until guide catheter disengagement.

  5. Contrast volume

    Time frame: During the procedure

    The total contrast volume used during the procedure.

  6. Patient radiation exposure

    Time frame: During the procedure

    Dose-area-product (DAP) as recorded during the procedure.

Other outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: From time of procedure until date of first event or death from any cause, which came first, assessed up to the time of discharge in the index hospitalization

    In-hospital MACE, the composite of death, target vessel MI, or need of repeat target vessel revascularization;

  2. Number of participants with stent thrombosis

    Time frame: 1 year post-procedure

    Stent thrombosis at 1 year, defined according to the ARC criteria;

  3. Bleeding events

    Time frame: 1 year post-procedure

    Bleeding events at 1 year, defined according to the Bleeding ARC (BARC).

  4. Manual input and/or conversion

    Time frame: During the procedure

    The incidence and reasons for manual input and/or conversion during R-PCI.

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana Zlahoda-Huzior, MSc

CONTACT

[email protected]

+48788624993

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Corindus, Inc. dba Siemens Healthineers Endovascular Robotics
  • KCRI Sp. z o.o.

Registry information

Official study title

Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry

Acronym: TESLA

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 3, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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