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.
Brief Title
PRECISION GRX Registry
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Coronary Artery Disease
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03278301
Org Class
Industry
Org Full Name
Corindus Inc.
Org Study Id
2017-001
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
Primary Outcomes
Outcome Description
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).
Outcome Measure
Clinical Success
Outcome Time Frame
Discharge or 72 hours post intervention, whichever comes first.
Outcome Description
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.
Outcome Measure
Technical Success
Outcome Time Frame
Procedure
Secondary Outcomes
Outcome Description
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Outcome Time Frame
Procedure
Outcome Measure
Overall Procedure Time
Outcome Description
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Outcome Time Frame
Procedure
Outcome Measure
PCI Procedure Time
Outcome Description
Total Fluoroscopy Time during procedure will be captured.
Outcome Time Frame
Procedure
Outcome Measure
Fluoroscopy Time
Outcome Description
DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
Outcome Time Frame
Procedure
Outcome Measure
Patient Radiation Exposure
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Subjects with coronary artery disease and with a clinical indication for PCI.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Giora Weisz
Investigator Email
gweisz@montefiore.org
Investigator Phone