PRECISION GRX Post-Market Study - Japan
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Robotic-assisted PCI
- Registration Number
- NCT03870087
- Lead Sponsor
- Corindus Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- Age ≥ 20 years;
- Patients with coronary artery disease with clinical indication for PCI;
- Patient deemed appropriate for robotic-assisted PCI; and
- 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.
- Failure/inability/unwillingness to provide informed consent, unless the EC has waived informed consent; or
- The Investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Robotic PCI Robotic-assisted PCI All subjects treated with CorPath GRX during the PCI procedure.
- Primary Outcome Measures
Name Time Method 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.
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).
- Secondary Outcome Measures
Name Time Method 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.
Overall Procedure Time During procedure Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
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.
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.
Fluoroscopy Time During procedure Total fluoroscopy utilized during the procedure as recorded by an Imaging System.
Trial Locations
- Locations (8)
Fukuoka Sanno Hospital
🇯🇵Fukuoka City, Fukuoka, Japan
Iwate University Hospital
🇯🇵Morioka, Iwate, Japan
Nayoro City General Hospital
🇯🇵Nayoro, Hokkaido, Japan
Toho University Ohashi Medical Center
🇯🇵Tokyo, Ohashi Meguro-ku, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Dokkyo Medical University Hospital
🇯🇵Mibu, Tochigi, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan