Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERobotic-assisted PCI
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.
Sponsors
Corindus Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | Discharge or 72 hours post intervention, whichever comes first. | 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). |
| Technical Success | Procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Procedure Time | Procedure | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. |
| PCI Procedure Time | Procedure | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
| Fluoroscopy Time | Procedure | Total Fluoroscopy Time during procedure will be captured. |
| Patient Radiation Exposure | Procedure | DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure. |
Countries
Brazil, India, Singapore, United States
Outcome results
None listed