Multicenter Registry on Robotically Assisted PCI - TESLA
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Number of participants with clinically successful PCI [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 Outcome Measures
- Number of participants with ischemia-driven target lesion revascularization (TLR) [1 year post-procedure]
Ischemia-driven target lesion revascularization (TLR), at 1 year defined according to the Academic Research Consortium (ARC) criteria;
- Number of participants with target lesion failure (TLF) [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;
- Number of participants with target vessel failure (TVF) [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.
- Procedure time [During the procedure]
The time recorded from initial guidewire insertion into the robotic drive until guide catheter disengagement.
- Contrast volume [During the procedure]
The total contrast volume used during the procedure.
- Patient radiation exposure [During the procedure]
Dose-area-product (DAP) as recorded during the procedure.
Other Outcome Measures
- Major adverse cardiovascular events (MACE) [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;
- Number of participants with stent thrombosis [1 year post-procedure]
Stent thrombosis at 1 year, defined according to the ARC criteria;
- Bleeding events [1 year post-procedure]
Bleeding events at 1 year, defined according to the Bleeding ARC (BARC).
- Manual input and/or conversion [During the procedure]
The incidence and reasons for manual input and/or conversion during R-PCI.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Older than 18 years,
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Patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI),
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Coronary artery lesions considered suitable for R-PCI with CorPath GRX System.
Exclusion Criteria:
- Unwillingness to provide informed consent (only if applicable).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii | Nowy Sacz | Malopolska | Poland | 33-300 |
Sponsors and Collaborators
- Clinical Research Center, Intercard Sp. z o.o.
- Corindus, Inc. dba Siemens Healthineers Endovascular Robotics
- KCRI Sp. z o.o.
Investigators
- Principal Investigator: Dariusz Dudek, MD, PhD, Clinical Research Center Intercard
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TESLA Protocol Version 2.1