SELUTION SLR™ 014 In-stent Restenosis

Criteria the registry did not label

• Clinical Inclusion Criteria:
• Subject age is ≥ 18 years or minimum legal age as required by local regulations.
• Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
• Subject presents with chronic coronary syndrome (CCS) (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST-elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for percutaneous coronary intervention (PCI) and planned intervention.
• Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator.
• Life expectancy \>1 year in opinion of investigator.
• Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
  • Angiographic Inclusion Criteria
• Target lesion is within a native coronary artery or major branch.
• Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent.
• Up to two (2) non-target lesions in non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before treatment of the target lesion. Successful treatment is defined as no greater than 30% residual stenosis by visual estimate, no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial Infarction (TIMI) grade flow in the non-target lesion \> 2.
• Target lesion is ≤ 26 mm in length.
• Target lesion has diameter stenosis of \> 50% and ≤ 99% by visual estimate.
• Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm.
• Target lesion must be successfully pre-dilated/pre-treated. Note: Successful pre-dilation/pre-treatment is defined as dilation or pre-treatment that achieves stent expansion of approximately 80% of the distal RVD (at the discretion of the investigator) based on intravascular ultrasound (IVUS)/optical coherence tomography (OCT) and no greater than 30% residual stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI grade flow in the target lesion must be \> 2. Note: Atherectomy and cutting balloon are permitted for pre-treatment.
  • Clinical Exclusion Criteria:
• Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
• ST-elevation myocardial infarction (STEMI) within 30 days.
• Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure.
• Target lesion is located within a bifurcation with planned treatment of side branch vessel.
• Target lesion is the 3rd or greater stent failure (i.e., more than two \[2\] layers of stent are present at any segment of the target lesion).
• Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.
• Previous PCI of the target vessel within 30 days.
• Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.
• Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m² within 30 days of index procedure) or has undergone renal transplantation.
• Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
• History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
• Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.
• Documented left ventricular ejection fraction (LVEF) \< 25%.
• Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
  • Angiographic Exclusion Criteria
• Target lesion is a total occlusion or has evidence of thrombus.
• Target lesion involves an unprotected left main.
• Target lesion has \> 30% residual stenosis by visual estimate or dissection greater than NHLBI type C after pre-dilation/pre-treatment.