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

Prior treatment

• PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
• Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
• Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
• Bleeding from any site requiring active medical attention within the prior 8 weeks
• Known allergy to the study device components or protocol-required concomitant medications:
  • \- sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
• Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
• Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
• Patient has received an organ transplant or is on a waiting list for an organ transplant
• Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
• 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
  • Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):
• ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
• Prior brachytherapy or DCB treatment of target lesion

Other illness

• If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
• Active infection undergoing treatment
• Clinically significant liver disease
• Active peptic ulcer or active bleeding from any site
• History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
• 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)
• Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
• Diffuse distal disease to target lesion with impaired runoff

Lab values

• Known left ventricular ejection fraction \<30%
• Hemoglobin \<9 g/dL
• Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• White blood cell count \<3,000 cells/mm3
• Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula

Other

• General Exclusion Criteria (all must be absent for the patient to be eligible):
• STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
• NSTEACS in whom the biomarkers have not peaked
• Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
• Subject is intubated
• Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
• Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
• Women who intend to become pregnant within 12 months after the index procedure
• More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
• Unprotected left main lesions \>50% or left main intervention
• Primary PCI for STEMI
• 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
• Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
• Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
• Target lesion contains large thrombus
• Target lesion is heavily calcified
• Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.\* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.

• 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:
  • Angiographic Inclusion Criteria:
• 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
• Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
• Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
• Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
• One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
• Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization