Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Japan Medicalnext, Co | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic PCI | All subjects treated with CorPath GRX during the PCI procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted PCI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual stenosis in the lesion(s) treated | 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). | Through end of subject's participation in the study, an average of up to 3 days. |
| 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. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | 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. | Through end of subject's participation in the study, an average of up to 3 days. |
| Overall Procedure Time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects with coronary artery disease and with a clinical indication for PCI.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Masato Nakamura, MD | Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka Sanno Hospital | Fukuoka | Fukuoka | 814-0001 | Japan | ||
| Kurume University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. |
| During procedure |
| PCI Procedure Time | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. | During procedure |
| IVUS/OCT/IVUS-OCT Time (if used) | 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. | During procedure |
| Fluoroscopy Time | Total fluoroscopy utilized during the procedure as recorded by an Imaging System. | During procedure |
| Patient Radiation Exposure | DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure. | During procedure |
| Operator Radiation Exposure | Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure. | During procedure |
| Kurume |
| Fukuoka |
| 830-0011 |
| Japan |
| Nayoro City General Hospital | Nayoro | Hokkaido | 096-8511 | Japan |
| Iwate University Hospital | Morioka | Iwate | 020-0023 | Japan |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Toho University Ohashi Medical Center | Tokyo | Ohashi Meguro-ku | 153-0044 | Japan |
| Dokkyo Medical University Hospital | Mibu | Tochigi | 321-0293 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |