The ROB-OSTIAL Study

Study Overview
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Brief Summary
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The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions. CorPath GRX System (the Device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices. It helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart. The results will help to evaluate whether procedures using the CorPath GRX result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard PCI.

Detailed Description
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To assess accuracy of robotic-assisted PCI in obtaining full ostial lesion coverage and minimal protrusion compared to standard PCI. Robotically assisted PCI offers the opportunity of performing minimal device movements (up to a minimum of 1 mm) in a stable and reproducible setting. This feature may be of great help when dealing with ostial lesions, whose treatment requires a precise stent positioning to avoid strut protrusion but also geographic miss of the lesion. Robotic-assisted PCI for ostial lesions showed encouraging results in large observational registries, but no study compared this approach with standard PCI. The aim is to perform a randomized (1:1) study comparing standard (n=33) and robotic-assisted PCI (n=33) in obtaining full lesion coverage when treating ostial lesions (ostial left main will be excluded). Primary endpoint of the study will be full ostial coverage as assessed by IVUS imaging, while secondary endpoints will be procedural success, vessel damage and number of protruding struts in the donor vessel as assessed by IVUS imaging.

Official Title
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Robotically Assisted PCI in Ostial Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Robotic-assisted PCI with Corpath GRX® System
* Procedure: Standard PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or nonpregnant female aged ≥18 years Coronary OSTIAL lesion suitable for percutaneous coronary intervention (PCI) The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: Cardiogenic shock or hemodynamic instability requiring support. ST-elevation myocardial infarction. Ongoing acute renal failure. In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status and/or anatomic characteristics More than one lesion to be treated Ostial left main disease

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic-assisted PCI with Corpath GRX® System<br>Percutaneous coronary intervention (PCI) using the Corpath GRX System. | Device: Robotic-assisted PCI with Corpath GRX® System<br>* The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary interventions (PCI).<br>|
| Active Comparator: Standard PCI<br>Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. | Procedure: Standard PCI<br>* Percutaneous coronary intervention (PCI) is a procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart. This arm will be completed without robotic assistance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of full ostial coverage at angiographic and IVUS assessment | Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS) | Measured at end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance from most proximal stent strut and coronary ostium (mm), as assessed by IVUS |  | Measured at end of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ostial Lesion, Robotic-assisted PCI, PCI