SELUTION 4 De Novo Small Vessel IDE Trial

Exclusion Criteria

• •Subjects who meet any of the following clinical criteria will be excluded from the trial:
• •1. Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
• •2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
• •3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
• •4. Subject with planned major surgery within 30 days following the index procedure.
• •5. Subject with planned treatment of lesion involving aorto-ostial location.
• •6. Subject with PCI of a non-target vessel within ± 30 days of the index procedure.
• •7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
• •8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).
• •9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
• •10. Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%.
• •11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
• •12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
• •13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.
• •14. 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 had undergone renal transplantation.
• •1. Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure.
• •2. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \>30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.
• •3. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.
• •4. Subject is concurrently enrolled in the main protocol angiographic registry.
• •5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir.
• •6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.
• •Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:
• •1. Target lesion is totally occluded or has evidence of thrombus.
• •2. Target lesion is located in the left main or any arterial or venous graft.
• •3. Target lesion is in a side branch that is "jailed" by a main vessel stent.
• •4. In stent restenosis