PRECISION GRX Registry

Siemens Healthineers Endovascular Robotics, Inc.952 enrolled

Overview

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Study Type

OBSERVATIONAL

Enrollment

952

Conditions

Coronary Artery Disease

Interventions

Robotic-assisted PCIDEVICE

The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Candidates will be included in the study only if all of the following conditions are met: 1. Age ≥18 years; 2. Patients with coronary artery disease with clinical indication for PCI; 3. Patient deemed appropriate for robotic-assisted PCI; and 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: * Candidates will be excluded from the study if any of the following conditions are present: 1. Failure/inability/unwillingness to provide informed consent; or 2. The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Locations (20)

UC San Diego Health Sulpizio Cardiovascular Center

San Diego, California, United States

Outcomes

Primary Outcomes

Clinical Success

Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).

Time frame: Discharge or 72 hours post intervention, whichever comes first.

Technical Success

Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.

Time frame: Procedure

Secondary Outcomes

Overall Procedure Time

Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

Time frame: Procedure

PCI Procedure Time

Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

Time frame: Procedure

Fluoroscopy Time

Total Fluoroscopy Time during procedure will be captured.

Time frame: Procedure

Patient Radiation Exposure

DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.

Time frame: Procedure

Data from ClinicalTrials.gov

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