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.
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
700
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.
Hartcentrum OLV Aalst
Aalst, Belgium
COMPLETEDSEGEBERGER Kliniken GmbH
Bad Segeberg, Germany
COMPLETEDUniversitätsklinikum Freiburg
Freiburg im Breisgau, Germany
COMPLETEDNumber 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);
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
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;
Time frame: 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;
Time frame: 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.
Time frame: 1 year post-procedure
Procedure time
The time recorded from initial guidewire insertion into the robotic drive until guide catheter disengagement.
Time frame: During the procedure
Contrast volume
The total contrast volume used during the procedure.
Time frame: During the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sapporo Cardiovascular Clinic
Sapporo, Japan
COMPLETEDCentrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
Nowy Sącz, Malopolska, Poland
RECRUITINGHospital Gregorio Maranon
Madrid, Spain
COMPLETEDPatient radiation exposure
Dose-area-product (DAP) as recorded during the procedure.
Time frame: During the procedure