Multicenter Registry on Robotically Assisted PCI - TESLA
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System
- Registration Number
- NCT05841745
- Lead Sponsor
- Clinical Research Center, Intercard Sp. z o.o.
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
- 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.
- Unwillingness to provide informed consent (only if applicable).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Robotically-Assisted Percutaneous Coronary Intervention Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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;
Patient radiation exposure During the procedure Dose-area-product (DAP) as recorded during the procedure.
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.
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;
Trial Locations
- Locations (6)
Hartcentrum OLV Aalst
🇧🇪Aalst, Belgium
SEGEBERGER Kliniken GmbH
🇩🇪Bad Segeberg, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Sapporo Cardiovascular Clinic
🇯🇵Sapporo, Japan
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
🇵🇱Nowy Sacz, Malopolska, Poland
Hospital Gregorio Maranon
🇪🇸Madrid, Spain