The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.
This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.
Study Type
OBSERVATIONAL
Enrollment
50
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. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist.
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. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be disabled.
Intercard Sp. Z o.o.
Nowy Sącz, Poland
Major Clinical and Angiographic Complications (MCAC)
The rate of the combined MCAC endpoint (a composite of MACE and Major Clinical and Angiographic Complications) in the technIQ ON group is not significantly higher than in the technIQ OFF group.
Time frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Technical Success
Residual stenosis of \<30% in all target lesions with final TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 by angiographic core lab analysis, AND absence of unplanned manual conversion.
Time frame: During the Procedure
PCI procedure time
Time between insertion of guide catheter and final removal of guide catheter.
Time frame: During the Procedure
Procedure success
The rate of procedure success in the technIQ ON group is not significantly lower than that in the technIQ OFF group.
Time frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Major adverse cardiovascular events (MACE),
Reported as a composite and components of Cardiac Death, Target Vessel MI, and Target Vessel Revascularization (TVR).
Time frame: 72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.
Major angiographic complications
Reported as perforation(Type 1, 2, 3) or flow-limiting dissection (Type E, F).
Time frame: During the Procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Serious Adverse Events (SAE)
All Serious Adverse Events (SAEs) from the start of the CorPath GRX PCI procedure through 72 hours postprocedure or hospital discharge (whichever occurs) first will be summarized
Time frame: Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)
Guidewire Wiring Time
The time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.
Time frame: During the Procedure
Fluoroscopy Time to Cross Lesion
The fluoroscopy time required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.
Time frame: During the Procedure
Contrast Used to Cross Lesion
The amount of contrast (in ml) required to advance the guidewire from the tip of the guide catheter to the final target distal to the lesion.
Time frame: During the Procedure
Total Procedural Time
The time from the start of the sheath insertion to complete removal of the final guide catheter.
Time frame: During the Procedure
Total Fluoroscopy Time
The total fluoroscopy time during the procedure as recorded by an Imaging System.
Time frame: During the Procedure
Subject Radiation Exposure
Dose-area-product (DAP) as recorded during the procedure
Time frame: During the Procedure
Subject Radiation Dose
air kerma (AK) as recorded during the procedure.
Time frame: During the Procedure
Contrast Fluid Volume
The total contrast volume used during the procedure.
Time frame: During the Procedure
Planned Manual Conversion (PMC)
Planned manual conversion (PMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was prespecified in the procedural plan (e.g., to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform, such as intravascular ultrasound or atherectomy devices). This will be assessed by a questionnaire.
Time frame: During the Procedure
Unplanned Manual Conversion (UMC)
Unplanned manual conversion (UMC) is disengagement of the robotic drive to use bedside manipulation of either the guide catheter, guidewire, or delivery system that was not prespecified in the procedural plan, and that was due to inability to navigate to the target lesion as intended, cross the target lesion as intended, treat the target lesion as intended, retract the CorPath GRX system as intended, or other CorPath system device malfunction; or any clinical condition that requires rapid medical intervention. This will be assessed by a questionnaire.
Time frame: During the Procedure
Partial Manual Assistance (PMA)
Partial manual assistance (PMA) is the use of manual techniques that were not prespecified in the procedural plan and do not meet the definition of unplanned manual conversion (e.g., unplanned use of manual techniques to accommodate adjunctive devices or procedural techniques that are not compatible with the robotic platform). These will be assessed by a questionnaire.
Time frame: During the Procedure
Device Malfunction
The device malfunction will report the inadequacy of the medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. Investigators are instructed to report all device deficiencies and device malfunctions using the device malfunction form in the EDC.
Time frame: During the Procedure