An observational study in Coronary Artery Disease, sponsored by Corindus Inc.. Completed at 20 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Corindus Inc. · Observational
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.
Subjects with coronary artery disease and with a clinical indication for PCI.
Candidates will be included in the study only if all of the following conditions are met:
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are present:
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Corindus Inc.