Multicenter Registry on Robotically Assisted PCI - TESLA

Coronary Artery Disease Clinical Trial

— TESLA  

Official title:

Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841745
• Other study ID #: TESLA Protocol Version 2.1
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Clinical Research Center, Intercard Sp. z o.o.
• Contact: Adriana Zlahoda-Huzior, MSc
• Phone: +48788624993
• Email: azlahoda[@]carint.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Poland	Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii	Nowy Sacz	Malopolska

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Research Center, Intercard Sp. z o.o.	Corindus, Inc. dba Siemens Healthineers Endovascular Robotics, KCRI Sp. z o.o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of participants with stent thrombosis	Stent thrombosis at 1 year, defined according to the ARC criteria;	1 year post-procedure
Other	Bleeding events	Bleeding events at 1 year, defined according to the Bleeding ARC (BARC).	1 year post-procedure
Other	Manual input and/or conversion	The incidence and reasons for manual input and/or conversion during R-PCI.	During the procedure
Primary	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	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
Secondary	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
Secondary	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
Secondary	Procedure time	The time recorded from initial guidewire insertion into the robotic drive until guide catheter disengagement.	During the procedure
Secondary	Contrast volume	The total contrast volume used during the procedure.	During the procedure
Secondary	Patient radiation exposure	Dose-area-product (DAP) as recorded during the procedure.	During the procedure