Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions

Study Overview
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Brief Summary
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To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.

Detailed Description
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This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Official Title
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A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions

Conditions
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Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

Intervention / Treatment
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* Procedure: CorPath-assisted Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system. The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study). Failure/inability/unwillingness to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Cohort<br>Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI) | Procedure: CorPath-assisted Percutaneous Coronary Intervention<br>* Robotic-assisted Percutaneous Coronary Intervention<br>* Other names: Robotic-assisted Percutaneous Coronary Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Success | Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE). | In-hospital (72-hours or discharge, whichever occurs first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With In-hospital Major Adverse Coronary Events (MACE) | The composite of death, myocardial infarction, and target vessel revascularization that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath 200 System. | In-hospital (72-hours or discharge, whichever occurs first) | 
| Number of Participants With an Adverse Event | All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) from the start of the CorPath procedure until the end of the study will be summarized. | In-hospital (72-hours or discharge, whichever occurs first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, robotic-assisted PCI, coronary intervention, CorPath PRECISION Registry, angioplasty