Multicenter Registry on Robotically Assisted PCI - TESLA (TESLA)

Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Adriana Zlahoda-Huzior, MSc; Phone Number: +48788624993; Email: azlahoda@carint.pl

Study Locations

• Poland
  • Malopolska
    • Nowy Sacz, Malopolska, Poland, 33-300
      • Recruiting
      • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
      • Contact: Maria Kundzierewicz, MSc; Email: m.kundzierewicz@intercard.net.pl
      • Sub-Investigator: Aleksander Zelias, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This registry will include at least 700 patients (up to 1000) who underwent R-PCI. All the international centers that have already utilized the CorPath GRX System have been invited to participate in this multicenter study. The final number of patients enrolled in the study will depend on the final number of participating centers and the number of patients treated with R-PCI with CorPath GRX System in each center. All patients who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System (Corindus Vascular) 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).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Robotically-Assisted Percutaneous Coronary Intervention; All patients older than 18 years, who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System (Corindus Vascular) and completed one-year follow-up including patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with clinically successful PCI	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);	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with ischemia-driven target lesion revascularization (TLR)	Ischemia-driven target lesion revascularization (TLR), at 1 year defined according to the Academic Research Consortium (ARC) criteria;	1 year post-procedure
Number of participants with target lesion failure (TLF)	Target lesion failure (TLF) at 1 year, the composite of ARC-defined cardiac death, target vessel MI, or ischemia-driven TLR;	1 year post-procedure
Number of participants with target vessel failure (TVF)	Target vessel failure (TVF) at 1 year, the composite of ARC-defined cardiac death, target vessel MI, or ischemia-driven TVR.	1 year post-procedure
Procedure time	The time recorded from initial guidewire insertion into the robotic drive until guide catheter disengagement.	During the procedure
Contrast volume	The total contrast volume used during the procedure.	During the procedure
Patient radiation exposure	Dose-area-product (DAP) as recorded during the procedure.	During the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events (MACE)	In-hospital MACE, the composite of death, target vessel MI, or need of repeat target vessel revascularization;	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
Number of participants with stent thrombosis	Stent thrombosis at 1 year, defined according to the ARC criteria;	1 year post-procedure
Bleeding events	Bleeding events at 1 year, defined according to the Bleeding ARC (BARC).	1 year post-procedure
Manual input and/or conversion	The incidence and reasons for manual input and/or conversion during R-PCI.	During the procedure

Collaborators and Investigators

• Sponsor: Clinical Research Center, Intercard Sp. z o.o.
• Collaborators: Corindus, Inc. dba Siemens Healthineers Endovascular Robotics; KCRI Sp. z o.o.
• Investigators: Principal Investigator: Dariusz Dudek, MD, PhD, Clinical Research Center Intercard

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Coronary artery disease; Robotically-assisted percutaneous coronary intervention; R-PCI registry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: TESLA Protocol Version 2.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes