MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

Inclusion criteria

• ✓. Subject is at least 18 years old
• ✓. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
• ✓. Patient with an indication for PCI due to suspected in-stent restenosis
• ✓. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
• ✓. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
• ✓. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
• ✓. Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
• ✓. Target lesion in a native coronary artery

Exclusion criteria