GRX With ReMOTE: First in Human in India

Study Overview
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Brief Summary
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To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Detailed Description
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Prospective, single-arm, single center, non-randomized feasibility study of the CorPath GRX POP System to examine its performance during remote angioplasty (ballooning) and stenting and patient outcomes through 48 hours post-PCI procedure hospital discharge, whichever occurs first.

Official Title
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CorPath GRX With ReMOTE Proof of Principle (POP): First in Human in India

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Remote treatment of PCI.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 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. Angiographic Inclusion: Study lesion is a single de novo native coronary artery lesion (i.e. a coronary lesion not previously treated). The lesion reference vessel diameter is between 2.50 mm and 4.0 mm by visual estimate. Study lesion length less or equal to 20 mm by visual estimate. The study lesion length can be treated with one stent. The stent should be able to cover the whole length of the lesion with at least 2 mm of normal segments on proximal and distal edges of the lesion. Study lesion diameter showing significant stenosis of at least 50% by visual estimate. Exclusion Criteria: Failure/inability/unwillingness to provide informed consent; or The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI. Angiographic Exclusion: Target lesion that cannot be fully covered by a single stent. Subject requires treatment of multiple lesions Any previous stent placement within 5 mm (proximal or distal) of the target lesion The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (> 90°) proximal to the target lesion The study lesion has any of the following characteristics: Total occlusion Within 2mm of a side branch > 2.0 mm vessel diameter Not ostial in location Is located at ≥ 45° bend in the vessel Is severely tortuous Is severely calcified Severe calcification at the part of the vessel proximal to target lesion Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass and is approached through the by-pass graft Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective, single-arm, single center, non-randomized feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Remote treatment of PCI.<br>5 sequential subjects presenting for remote PCI who have signed informed consent. | Device: Remote treatment of PCI.<br>* To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.<br>* Other names: CorPath GRX and Proof of Principle System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Technical Success | Defined as completing the robotic PCI entirely with the CorPath GRX POP System. | Measured from guide catheter in time through procedure end time (or guide catheter out time). | 
| In-hospital MACE | Recording any MACE event that occurred from the time the sheath was inserted through 48 hours post procedure or hospital discharge, whichever of the two occurred first. | Measured from Sheath in time to discharge or 48 hours, whichever occurs first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Procedural Success | Number of patients with a residual stenosis (visual estimate, less than 30%) post PCI in the lesion(s) treated with the CorPath GRX POP System. | Measured from guide catheter in time through procedure end time (or guide catheter out time). | 
| All Serious Adverse Events | Recording any SAE that occurred measured from the sheath insertion time through 48 hours post procedure or hospital discharge, whichever occurred first. | Measured from Sheath in time to discharge or 48 hours, whichever occurs first. |