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

Inclusion Criteria:

1. Subject is at least 18 years old

2. Subject (or legal guardian) understands the trial requirements and treatmentprocedures and provides written informed consent prior to any trial-specific testsor 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 approvedinterventional devices prior to randomization as follows:

Angiographic Inclusion Criteria:

1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)

2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameterstenosis in symptomatic patients; or a visually estimated target lesion diameterstenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flowreserve [FFR] ≤0.80 or non-hyperemic pressure ratio [NHPR] ≤0.89) in absence ofsymptoms

3. Successful lesion preparation (residual stenosis <30%), without complications (no orslow flow, flow-limiting dissection, perforation, distal embolization) and withoutplan for stenting

4. Target lesion in a native coronary artery

5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion

6. Target reference vessel diameter (visual estimation) >2.0 and ≤4.0 mm

7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and canbe covered by only one balloon

8. One ISR target lesion (overlapping stents are allowed) to be treated per patient andin single major coronary artery or side branch (reference vessel diameter >2.0 mm)

9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may betreated by any approved interventional device, but must be treated successfullyprior to randomization

Exclusion Criteria:

General Exclusion Criteria (all must be absent for the patient to be eligible):

1. STEMI within 72 hours of presentation to the first treating hospital, whether atransfer 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 innon-target lesions during the index procedure)

4. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR

5. Cardiogenic shock (defined as persistent hypotension [systolic blood pressure <90 mmHg] or requiring vasoactive or hemodynamic support, including IABP)

6. Subject is intubated

7. Known left ventricular ejection fraction <30%

8. Relative or absolute contraindication to DAPT for at least 1 month (e.g., plannedsurgeries that cannot be delayed)

9. Subject has an indication for chronic oral anticoagulation treatment and acontraindication for concomitant treatment with a P2Y12 inhibitor

10. If femoral access is planned, significant peripheral arterial disease whichprecludes safe insertion of a 6F sheath

11. Hemoglobin <9 g/dL

12. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3

13. White blood cell count <3,000 cells/mm3

14. Active infection undergoing treatment

15. Clinically significant liver disease

16. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be <30ml/min by the MDRD formula

17. Active peptic ulcer or active bleeding from any site

18. Bleeding from any site requiring active medical attention within the prior 8 weeks

19. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions

20. Cerebrovascular accident (CVA) within 3 months or has any permanent neurologicaldefect as a result of CVA

21. Known allergy to the study device components or protocol-required concomitantmedications:

• sirolimus (as well as other limus drugs, analogues, or similar compounds),aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, oriodinated contrast that cannot be adequately pre-medicated

22. 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)

23. Patient is participating in or plans to participate in any other investigationaldrug or device trial that has not reached its primary endpoint

24. Women who are pregnant or breastfeeding (women of child-bearing potential must havea negative pregnancy test within one week before index procedure)

25. Women who intend to become pregnant within 12 months after the index procedure

26. Patient has received an organ transplant or is on a waiting list for an organtransplant

27. Patient has received chemotherapy within 30 days before the index procedure orscheduled to receive chemotherapy any time after the index procedure

28. Patient is receiving oral or intravenous immunosuppressive therapy or has knownlife-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroiduse for contrast- allergy prophylaxis or treatment are allowed

Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):

1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by asingle 40mm length DCB (see Angiographic Inclusions #5 and #6 above)

2. ISR lesion in the target vessel in a segment that corresponds to a previouslyestablished/documented bare metal stent (BMS)

3. Unprotected left main lesions >50% or left main intervention

4. Primary PCI for STEMI

5. Coronary artery disease judged more suitable for surgical revascularization perguidelines and local heart team discussion

6. Another lesion in either the target vessel or non-target vessel is present thatrequires or has a high probability of requiring PCI within 12 months after the indexprocedure

7. Prior brachytherapy or DCB treatment of target lesion

8. Target lesion is a bifurcation restenosis involving both branches of a bifurcationin which the side branch reference vessel diameter is >2.0 mm

9. Target lesions located within an arterial or saphenous vein graft or distal to adiseased arterial or saphenous vein graft

10. Target lesion contains large thrombus

11. Target lesion is heavily calcified

12. Target lesion is a chronic total occlusion (or subtotal) without adequate lesionpreparation.* Total and subtotal occlusions may be enrolled assuming they can becrossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.

13. Diffuse distal disease to target lesion with impaired runoff