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

Eligibility Criteria

• 1. Subject is at least 18 years old
• 2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
• 3. Patient with an indication for PCI due to suspected in-stent restenosis
• 4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
• 1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
• 2. NSTEACS in whom the biomarkers have not peaked
• 3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
• 4. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
• 5. Subject is intubated
• 6. Known left ventricular ejection fraction \<30%
• 7. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
• 8. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
• 9. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
• 10. Hemoglobin \<9 g/dL
• 11. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• 12. White blood cell count \<3,000 cells/mm3
• 13. Active infection undergoing treatment
• 14. Clinically significant liver disease
• 15. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula
• 16. Active peptic ulcer or active bleeding from any site
• 17. Bleeding from any site requiring active medical attention within the prior 8 weeks
• 18. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
• 19. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
• 20. Known allergy to the study device components or protocol-required concomitant medications:
• 21. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
• 22. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
• 23. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
• 24. Women who intend to become pregnant within 12 months after the index procedure
• 25. Patient has received an organ transplant or is on a waiting list for an organ transplant
• 26. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
• 27. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed
• 1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40 mm length DCB (see Angiographic Inclusions #5 and #6 above)
• 2. Unprotected left main lesions \>50% or left main intervention
• 3. Primary PCI for STEMI
• 4. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
• 5. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
• 6. Prior brachytherapy or DCB treatment of target lesion
• 7. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
• 8. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
• 9. Target lesion contains large thrombus
• 10. Target lesion is heavily calcified
• 11. Target lesion is a chronic total occlusion
• 12. Diffuse distal disease to target lesion with impaired runoff