GRX With ReMOTE: First in Human in India

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.

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)