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 in the first 231 patients treated with the CorPath device in Japan.
Detailed description
This is a single-arm, open-label, multi-center patient registry in Japan 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
Japan Medicalnext, Co
Corindus Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 20 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, unless the EC has waived informed consent.
Exclusion criteria
1. Failure/inability/unwillingness to provide informed consent, unless the EC has waived 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 |
|---|---|---|
| Residual stenosis in the lesion(s) treated | Through end of subject's participation in the study, an average of up to 3 days. | Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse cardiac events (MACE) as assessed by the Angiographic Core Laboratory (ACL). |
| Technical Success | During 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 |
|---|---|---|
| PCI Procedure Time | During procedure | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
| IVUS/OCT/IVUS-OCT Time (if used) | During procedure | Defined as the total time measured from insertion of the imaging catheter \[Intravascular Ultrasound (IVUS), Optical Coherence Tomography (OCT) or integrated IVUS-OCT (IVUS-OCT)\] until the removal of the imaging catheter. |
| Major adverse cardiac events (MACE) | Through end of subject's participation in the study, an average of up to 3 days. | MACE that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath GRX System. |
| Patient Radiation Exposure | During procedure | DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure. |
| Operator Radiation Exposure | During procedure | Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure. |
| Fluoroscopy Time | During procedure | Total fluoroscopy utilized during the procedure as recorded by an Imaging System. |
| Overall Procedure Time | During procedure | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. |
Countries
Japan
Outcome results
None listed